Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations
SPARK
A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
2 other identifiers
interventional
2,224
27 countries
337
Brief Summary
This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Apr 2010
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
337 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
September 30, 2013
CompletedDecember 2, 2013
October 1, 2013
2.3 years
May 5, 2010
July 9, 2013
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years
64 weeks
Secondary Outcomes (12)
Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.
76 weeks
Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period
64 weeks
Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics
64 weeks
Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics
64 weeks
Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.
64 weeks
- +7 more secondary outcomes
Study Arms (3)
QVA149
EXPERIMENTALQVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
NVA237
ACTIVE COMPARATORNVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
open-label tiotropium
ACTIVE COMPARATOROpen-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
Interventions
QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
Eligibility Criteria
You may qualify if:
- Male or female adults aged ≥40 years, who had signed an informed consent form prior to initiation of any study-related procedure.
- Patients with severe to very severe Chronic Obstructive Pulmonary Disease COPD (Stage III or IV) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
- Current or ex-smokers with a smoking history of at least 10 pack years (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
- Patients with a post-bronchodilator Forced Expiratory Volume in one second ( FEV1) \<50% of the predicted normal value, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) \<0.70 at Visit 2 (day -14). (Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol).
- A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics.
You may not qualify if:
- Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
- Women of child-bearing potential
- Patients requiring long term oxygen therapy (\> 15 h a day) on a daily basis for chronic hypoxemia.
- Patients who had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to visit 1 or between visit 1 (Day -21) and Visit 3 (Day 1).
- Patients who developed a COPD exacerbation during a period between visit 1 and 3 were ineligible but were permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
- Patients who had a respiratory tract infection within 4 weeks prior to visit 1 (Day -21)
- Patients who developed an upper or lower respiratory tract infection during the screening period (up to visit 3 (Day 1) were not eligible, but were permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
- Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
- Patients with lung lobectomy, or lung volume reduction or lung transplantation.
- Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
- history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- uncontrolled hypo- or hyperthyroidism, hypokalemia or hyper adrenergic state
- narrow-angle glaucoma
- Symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (Patients with a Transurethral Resection of Prostate (TURP) were excluded from the study. Patients who underwent full re-section of the prostate could be considered for the study, as well as patients who were asymptomatic and stable on pharmacological treatment for the condition).
- any condition which might have compromised patient safety or compliance, interfered with evaluation, or precluded completion of the study
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (342)
Novartis Investigative Site
Birmingham, Alabama, 35233, United States
Novartis Investigative Site
Fairhope, Alabama, 36532, United States
Novartis Investigative Site
Florence, Alabama, 35630, United States
Novartis Investigative Site
Homewood, Alabama, 35209-6870, United States
Novartis Investigative Site
Jasper, Alabama, 35501, United States
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Pine Bluff, Arkansas, 71603, United States
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Fullerton, California, 92835, United States
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Palo Alto, California, 94304-1207, United States
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Riverside, California, 92506, United States
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San Diego, California, 92101, United States
Novartis Investigative Site
San Diego, California, 92103-8415, United States
Novartis Investigative Site
San Diego, California, 92120, United States
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Stockton, California, 95207, United States
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Gainesville, Florida, 32608, United States
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Miami, Florida, 33125, United States
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Pensacola, Florida, 32503, United States
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Couer D'Alene, Idaho, 83814, United States
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Normal, Illinois, 61761, United States
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River Forest, Illinois, 60305, United States
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Florence, Kentucky, 41042, United States
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Louisville, Kentucky, 40206, United States
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Opelousas, Louisiana, 70570, United States
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Bangor, Maine, 04401, United States
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Fridley, Minnesota, 55432, United States
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Ozark, Missouri, 65721, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59804, United States
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Papillion, Nebraska, 68046, United States
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Henderson, Nevada, 89014, United States
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Las Vegas, Nevada, 89119, United States
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Reno, Nevada, 89520, United States
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Great Neck, New York, 11021, United States
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Massapequa, New York, 11758, United States
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Charlotte, North Carolina, 28207, United States
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Raleigh, North Carolina, 27607, United States
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Wilmington, North Carolina, 28401, United States
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Columbus, Ohio, 43213, United States
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Medford, Oregon, 97504-8741, United States
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Portland, Oregon, 97213, United States
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Beaver, Pennsylvania, 15009, United States
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Erie, Pennsylvania, 16508, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Charleston, South Carolina, 29406-7108, United States
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Spartanburg, South Carolina, 29303, United States
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Dallas, Texas, 75216, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Fort Worth, Texas, 76107, United States
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Salt Lake City, Utah, 84107, United States
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Salem, Virginia, 24153, United States
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Tacoma, Washington, 98405, United States
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Green Bay, Wisconsin, 54311, United States
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Paraná Entre Ríos, Argentina, 3100, Argentina
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Buenos Aires, Buenos Aires, B1842DID, Argentina
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Buenos Aires, Buenos Aires, B1878FNR, Argentina
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Buenos Aires, Buenos Aires, B2705XAE, Argentina
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Buenos Aires, Buenos Aires, B8000XAV, Argentina
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Buenos Aires, Buenos Aires, C1013AAR, Argentina
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Buenos Aires, Buenos Aires, C1115AAB, Argentina
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Buenos Aires, Buenos Aires, C1120AAC, Argentina
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Buenos Aires, Buenos Aires, C1122AAK, Argentina
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Buenos Aires, Buenos Aires, C1125ABE, Argentina
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Buenos Aires, Buenos Aires, C1405BCH, Argentina
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Buenos Aires, Buenos Aires, C1425AUA, Argentina
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Buenos Aires, Buenos Aires, C1425BEA, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, C1424BSF, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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San Isidro, Buenos Aires, B1609EEO, Argentina
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Corrientes, Corrientes Province, 3400, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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Mendoza, Mendoza Province, 5500, Argentina
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Mendoza, Mendoza Province, M5500CCG, Argentina
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Rosario, Santa Fe Province, C2000DSR, Argentina
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Rosario, Santa Fe Province, S2000DBS, Argentina
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Santa Fe, Santa Fe Province, S3000FIL, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000DGF, Argentina
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Buenos Aires, 1428, Argentina
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Buenos Aires, B6500EZL, Argentina
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Buenos Aires, C1186ACB, Argentina
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Buenos Aires, C1440BRR, Argentina
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Feldbach, Austria, 8330, Austria
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Grieskirchen, Austria, 4710, Austria
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Linz, Austria, 4020, Austria
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Salzburg, Austria, 5020, Austria
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Thalheim bei Wels, Austria, 4600, Austria
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Edmonton, Alberta, T6G 2B7, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Joliette, Quebec, J6E 6J2, Canada
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Laval, Quebec, H7S 2M5, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Québec, Quebec, G1G 3Z4, Canada
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Québec, Quebec, G1P 1J6, Canada
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Saint Romuald, Quebec, G6W 5M6, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Medellín, Colombia, Colombia
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Bogota, Cundinamarca, Colombia
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Armenia, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Medellín, Colombia
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Cvikov, Czech Republic, 471 54, Czechia
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Český Krumlov, Czech Republic, 381 01, Czechia
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Havlíčkův Brod, Czech Republic, 580 01, Czechia
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Jaroměř, Czech Republic, 551 01, Czechia
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Karlovy Vary, Czech Republic, 360 66, Czechia
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Kroměříž, Czech Republic, 767 55, Czechia
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Kutná Hora, Czech Republic, 284 01, Czechia
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Kyjov, Czech Republic, 697 01, Czechia
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Liberec, Czech Republic, 460 01, Czechia
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Pardubice, Czech Republic, 530 09, Czechia
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Prague, Czech Republic, 108 00, Czechia
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Prague, Czech Republic, 142 00, Czechia
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Prague, Czech Republic, 198 00, Czechia
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Rokycany, Czech Republic, 337 22, Czechia
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Strakonice, Czech Republic, 38601, Czechia
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Teplice, Czech Republic, 415 01, Czechia
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Znojmo, Czech Republic, 669 02, Czechia
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Žatec, Czech Republic, 438 01, Czechia
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Aalborg, Denmark, DK-9100, Denmark
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Hellerup, Denmark, DK-2900, Denmark
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Hvidovre, Denmark, DK-2650, Denmark
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Roskilde, Denmark, DK-4000, Denmark
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Silkeborg, Denmark, 8600, Denmark
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Sønderborg, Denmark, DK-6400, Denmark
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Copenhagen NV, DK-2400, Denmark
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Tallinn, Estonia, 10138, Estonia
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Tartu, Estonia, 51014, Estonia
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Tallinn, 13419, Estonia
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Helsinki, Finland, 00029, Finland
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Jyväskylä, Finland, 40100, Finland
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Turku, Finland, FIN-20100, Finland
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Beuvry, France, 62660, France
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Ferolles-Attily, France, 77150, France
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Bayonne, 64109, France
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Montpellier, 34059, France
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Paris, 75013, France
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Berlin, Germany, 10117, Germany
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Berlin, Germany, 10969, Germany
Novartis Investigative Site
Berlin, Germany, 14050, Germany
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Dresden, Germany, 01307, Germany
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Heidelberg, Germany, 69117, Germany
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Leipzig, Germany, 04207, Germany
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Marburg, Germany, 35037, Germany
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München, Germany, 80331, Germany
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Potsdam, Germany, 14467, Germany
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Teterow, Germany, 17166, Germany
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Koblenz, North Rhine-Westphalia, 56068, Germany
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Aschaffenburg, 63739, Germany
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Bamberg, 96049, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 12043, Germany
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Berlin, 12165, Germany
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Berlin, 12203, Germany
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Berlin, 13086, Germany
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Berlin, D-12165, Germany
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Bochum, 44787, Germany
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Bonn, 53119, Germany
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Duisburg, 47057, Germany
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Düren, 52349, Germany
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Frankfurt, 60596, Germany
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Freudenberg, 57258, Germany
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Fulda, 36039, Germany
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Gelsenkirchen, 45879, Germany
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Gummersbach, 51643, Germany
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Hagen, 59065, Germany
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Halle, 06108, Germany
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Hamburg, 20354, Germany
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Hamburg, 22299, Germany
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Hanover, 30167, Germany
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Homburg, 66424, Germany
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Kiel, 24148, Germany
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Langenfeld, 40764, Germany
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Leipzig, 04357, Germany
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Lübeck, 23558, Germany
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Nuremberg, 90419, Germany
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Oranienburg, 16515, Germany
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Radebeul, 01445, Germany
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Reinfeld, 23858, Germany
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Saarbrücken, 66111, Germany
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Schwerte, 58239, Germany
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Schwetzingen, 68723, Germany
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Solingen, 42651, Germany
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Stade, 21680, Germany
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Wissen, 57537, Germany
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Larissa, Greece, 41110, Greece
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Athens, GR 11527, Greece
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Athens, GR 12461, Greece
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Athens, GR-106 76, Greece
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Athens - GR, 10676, Greece
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Thessaloniki, GR 570 10, Greece
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Thessaloniki, GR56403, Greece
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Cegléd, Hungary, 2700, Hungary
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Debrecen, Hungary, 4032, Hungary
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Szarvas, Hungary, 5540, Hungary
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Baja, 6500, Hungary
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Budapest, 1125, Hungary
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Deszk, 6772, Hungary
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Eger, 3300, Hungary
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Makó, 6900, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Sopron, 9400, Hungary
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Szekszárd, 7100, Hungary
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Hyderabad, A.p., 500 001, India
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Hyderbabd, Andhra Pradesh, 500 029, India
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Nagpur - Maharastra, India, 400 012, India
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Trivandrum, India, 695011, India
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Mysore, Karnataka, 570004, India
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Nashik, Maharashtra, 422005, India
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Pune, Maharashtra, 411 014, India
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New Delhi, National Capital Territory of Delhi, 110029, India
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Jaipur, Rajasthan, 302004, India
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Coimbatore, Tamil Nadu, 641 002, India
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Coimbatore, Tamil Nadu, 641004, India
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Coimbatore, Tamil Nadu, 641014, India
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Panjim, 403002, India
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Secunderabad, 500002, India
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Dublin, Ireland, Ireland
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Dublin, Ireland
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Ashkelon, 78278, Israel
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Beersheba, 84101, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Osimo, AN, 60027, Italy
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Catania, CT, 95125, Italy
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Foggia, FG, 71100, Italy
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Florence, FI, 50134, Italy
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Arenzano, GE, 16011, Italy
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Pisa, Italy, 56124, Italy
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Milan, MI, 20121, Italy
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Abano Terme, PD, 35031, Italy
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Perugia, PG, 06129, Italy
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Pisa, PI, 56124, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00128, Italy
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Riccione, RN, 47838, Italy
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Siena, SI, 53100, Italy
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Pietra Ligure, SV, 17027, Italy
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Montecchio Maggiore, VI, 36075, Italy
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Guadalajara, Jalisco, 44670, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Mexico City, Mexico City, 06726, Mexico
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Mexico City, Mexico City, 14050, Mexico
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Monterrey, Nuevo León, 64450, Mexico
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San Luis Potosí City, San Luis Potosí, 78218, Mexico
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Almelo, Netherlands, 7609 PP, Netherlands
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Breda, Netherlands, 4819 EV, Netherlands
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Enschede, Netherlands, 7513 ER, Netherlands
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Harderwijk, Netherlands, 3840 AC, Netherlands
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Helmond, Netherlands, 5707 HA, Netherlands
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Dordrecht, 3318AT, Netherlands
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Drachten, 9200 DA, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Hoorn, 1624 NP, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Roermond, 6043 CV, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Voorburg, 2275 CX, Netherlands
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Lima Cercado, Lima region, 01, Peru
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San Borja, Lima region, 41, Peru
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San Isidro, Lima region, 27, Peru
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San Martín de Porres, Lima region, 31, Peru
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San Miguel, Lima region, 32, Peru
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Santiago de Surco, Lima region, 33, Peru
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Quezon City, National Capital Region, 1109, Philippines
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Bulacan, Philippines, 3020, Philippines
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Las Piñas, 1740, Philippines
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Manila, Philippines
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Quezon City, 1100, Philippines
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Bialystok, 15-010, Poland
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Katowice, 40-752, Poland
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Krakow, 30-067, Poland
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Krakow, 31-159, Poland
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Lublin, 20-637, Poland
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Mrozy, 05-320, Poland
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Warsaw, 01-456, Poland
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Humacao, 00791, Puerto Rico
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Kazan', Tatarstan Republic, 420015, Russia
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Barnaul, 656045, Russia
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Chelyabinsk, 454021, Russia
Novartis Investigative Site
Moscow, 105229, Russia
Novartis Investigative Site
Moscow, 127018, Russia
Novartis Investigative Site
Rostov-on-Don, 344090, Russia
Novartis Investigative Site
Ryazan, 390026, Russia
Novartis Investigative Site
S.-Petersburg, 196247, Russia
Novartis Investigative Site
Saint Petersburg, 191015, Russia
Novartis Investigative Site
Saint Petersburg, 193312, Russia
Novartis Investigative Site
Saint Petersburg, 194354, Russia
Novartis Investigative Site
Saint Petersburg, 197022, Russia
Novartis Investigative Site
Saint Petersburg, 198013, Russia
Novartis Investigative Site
Saint Petersburg, 198044, Russia
Novartis Investigative Site
Samara, 443079, Russia
Novartis Investigative Site
Yaroslavl, 150010, Russia
Novartis Investigative Site
Yekaterinburg, 620109, Russia
Novartis Investigative Site
Banská Bystrica, Slovak Republic, 975 17, Slovakia
Novartis Investigative Site
Bojnice, Slovak Republic, 972 01, Slovakia
Novartis Investigative Site
Humenné, Slovak Republic, 066 01, Slovakia
Novartis Investigative Site
Partizánske, Slovak Republic, 958 01, Slovakia
Novartis Investigative Site
Košice, Slovakia, 040 01, Slovakia
Novartis Investigative Site
Kráľovský Chlmec, Slovakia, 077 01, Slovakia
Novartis Investigative Site
Martin, Slovakia, 03601, Slovakia
Novartis Investigative Site
Prešov, Slovakia, 080 01, Slovakia
Novartis Investigative Site
Trnava, Slovakia, 917 75, Slovakia
Novartis Investigative Site
Durban, South Africa, 4001, South Africa
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Newtown, Johannesburg, 2193, South Africa
Novartis Investigative Site
Pretoria, 0181, South Africa
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Pretoria, 0184, South Africa
Novartis Investigative Site
Pretoria, South Africa
Novartis Investigative Site
Alicante, Alicante, 03114, Spain
Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Novartis Investigative Site
A Coruña, Galicia, 15006, Spain
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Valencia, Valencia, Spain
Novartis Investigative Site
Stockton, Cleveland, TS19 8PE, United Kingdom
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Sneinton, Nottingham, NG3 7DQ, United Kingdom
Novartis Investigative Site
Taunton, Somerset, TA1 3JL, United Kingdom
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Chertsey, Surrey, KT16 0PZ, United Kingdom
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Blackpool, FY3 8NR, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Bristol, BS10 5NB, United Kingdom
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Coventry, CV6 4DD, United Kingdom
Novartis Investigative Site
Gillingham, ME7 5NY, United Kingdom
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Glasgow, G21 3UW, United Kingdom
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Hereford, HR1 2ER, United Kingdom
Novartis Investigative Site
Huntingdon, PE29 6NT, United Kingdom
Novartis Investigative Site
London, NW3 2PR, United Kingdom
Novartis Investigative Site
Manchester, M23 9QZ, United Kingdom
Novartis Investigative Site
Merseyside, CH49 5PE, United Kingdom
Novartis Investigative Site
Portsmouth, PO6 3AD, United Kingdom
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Telford, TF1 6TF, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.
PMID: 24429126DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 11, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
December 2, 2013
Results First Posted
September 30, 2013
Record last verified: 2013-10