Exacerbation Study
INVIGORATE
A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
2 other identifiers
interventional
3,439
37 countries
387
Brief Summary
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
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 Mar 2009
Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease
387 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
First Submitted
Initial submission to the registry
February 15, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
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
November 19, 2013
CompletedNovember 19, 2013
September 1, 2013
3.3 years
February 15, 2009
July 3, 2013
September 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in 1 Second (FEV1).
The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
12 weeks
Secondary Outcomes (1)
Rate of COPD Exacerbations
52 weeks
Study Arms (2)
Indacaterol
EXPERIMENTALIndacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium
ACTIVE COMPARATORTiotropium 18 µg o.d. delivered via the handihaler®
Interventions
Eligibility Criteria
You may qualify if:
- Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
- Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
- Smoking history of at least 10 pack years, both current and ex-smokers are eligible
- A documented history of at least 1 moderate or severe exacerbation in the previous 12 months
You may not qualify if:
- Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Patients with diabetes Type I or uncontrolled diabetes Type II
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular comorbid conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (423)
Novartis Investigative Site
Buenos Aires, Buenos Aires, 5000, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, B1842DID, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1122AAK, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1221ADC, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1426ABP, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Capital Federal, Buenos Aires, C1424BSF, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600, Argentina
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Pilar, Buenos Aires, B1629AHJ, 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, S2000AYW, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Novartis Investigative Site
Bankstown, New South Wales, 2200, Australia
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Adelaide, South Australia, 5000, Australia
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Daw Park, South Australia, 5041, Australia
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Heidelberg, Victoria, 3084, Australia
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Parkville, Victoria, 3050, Australia
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Nedlands, Western Australia, 6009, Australia
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Tauranga, New Zealand, 3001, Australia
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Feldbach, Austria, 8330, Austria
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Gänserndorf, Austria, 2230, Austria
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Grieskirchen, Austria, 4710, Austria
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Hallein, Austria, 5400, Austria
Novartis Investigative Site
Linz, Austria, 4020, Austria
Novartis Investigative Site
Perg, Austria, 4320, Austria
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Zwettl Stadt, Austria, 3910, Austria
Novartis Investigative Site
Framerie, Belgium, 7080, Belgium
Novartis Investigative Site
Geraardsbergen, Belgium, 9500, Belgium
Novartis Investigative Site
Gilly, Belgium, 6060, Belgium
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Malmedy, Belgium, 4960, Belgium
Novartis Investigative Site
Menen, Belgium, 8930, Belgium
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Aalst, 9300, Belgium
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Antwerp, 2020, Belgium
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Brussels, 1000, Belgium
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Brussels, 1200, Belgium
Novartis Investigative Site
Duffel, 2570, Belgium
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Eupen, 4700, Belgium
Novartis Investigative Site
Godinne, 5530, Belgium
Novartis Investigative Site
Gozée, 6534, Belgium
Novartis Investigative Site
Herentals, 2200, Belgium
Novartis Investigative Site
Jambes, 5100, Belgium
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Jette, 1090, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Montigny-le-Tilleul, 6110, Belgium
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Namur, 5000, Belgium
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Ostend, 8400, Belgium
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Turnhout, 2300, Belgium
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Goiânia, Goiás, 74605-050, Brazil
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Juiz de Fora, Minas Gerais, 36036-110, Brazil
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Rio de Janeiro, Rio de Janeiro, 22271-110, Brazil
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Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
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São Paulo, São Paulo, 04023-062, Brazil
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Calgary, Alberta, T2N 4N1, Canada
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Calgary, Alberta, T2V 1P9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Kelowna, British Columbia, V1Y 1E4, Canada
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Vancouver, British Columbia, V5Z 3J5, Canada
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Winnipeg, Manitoba, R3C 0N2, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Mississauga, Ontario, L5B 4A9, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Ottawa, Ontario, K1Y 4G2, Canada
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Toronto, Ontario, M5G1N8, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Toronto, Ontario, M6H 3M2, Canada
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Montreal, Quebec, H2L 2W5, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H2X 2P4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Sainte-Foy, Quebec, G1V 4G5, Canada
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Sherbrooke, Quebec, J1H 4J6, Canada
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Shijiazhuang, Hebei, 050000, China
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Changsha, Hunan, 410003, China
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Changsha, Hunan, 410011, China
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Shengyang, Liaoning, 110016, China
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Xi’an, Shanxi, 710032, China
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Xi’an, Shanxi, 710061, China
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Beijing, 100020, China
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Beijing, 100034, China
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Chongqing, 400037, China
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Shanghai, 200025, China
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Shenyang, 110001, China
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Barranquilla, Colombia
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Bogotá, Colombia
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Medellín, Colombia
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San Francisco de Asís, Costa Rica, Costa Rica
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San José, Costa Rica, Costa Rica
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Beroun, Czech Republic, Czechia
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Cvikov, Czech Republic, 471 54, Czechia
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České Budějovice, Czech Republic, 370 87, Czechia
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Český Krumlov, Czech Republic, 381 01, Czechia
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Karlovy Vary, Czech Republic, 360 06, Czechia
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Karlovy Vary, Czech Republic, 360 66, Czechia
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Kuřim, Czech Republic, 66434, Czechia
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Ostrava, Czech Republic, 70030, Czechia
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Ostrava - Hrabuvka, Czech Republic, 70030, Czechia
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Prague, Czech Republic, 169 00, Czechia
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Přerov, Czech Republic, 75000, Czechia
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Rokycany, Czech Republic, 337 22, Czechia
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Rudná, Czech Republic, 25219, Czechia
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Strakonice, Czech Republic, 38601, Czechia
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Teplice, Czech Republic, 415 01, Czechia
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Žatec, Czech Republic, 438 01, Czechia
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Kyjov, CZE, 697 70, Czechia
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Nový Jičín, 741 01, Czechia
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Aalborg, Denmark, DK-9100, Denmark
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Elsinore, Denmark, DK-3000, Denmark
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Hellerup, Denmark, DK-2900, Denmark
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Hvidovre, Denmark, DK-2650, Denmark
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Aarhus, DK-8000, Denmark
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Copenhagen NV, DK-2400, Denmark
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Odense C, DK-5000, Denmark
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Tartu, Estonia, 51014, Estonia
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Rakvere, 44310, Estonia
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Tallinn, 13619, 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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HUS, 00029, Finland
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Pori, FIN-28500, Finland
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Porvoo, FIN-06200, Finland
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Tampere, FIN-33521, Finland
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Beuvry, France, 62660, France
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Bourges, France, 18000, France
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Ferolles-Attily, France, 77150, France
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Lyon, 69317, France
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Montpellier, 34059, France
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Nantes, 44000, France
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Nice, 06602, France
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Ollioules, 83192, France
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Paris, 75006, France
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Perpignan, 66025, France
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Pessac, 33604, France
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Reims, 51092, France
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Saint-Michel-sur-Orge, 16470, France
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Vandœuvre-lès-Nancy, 54511, France
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Berlin, Germany, 10969, Germany
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Berlin, Germany, 14050, Germany
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Leipzig, Germany, 04207, Germany
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Mainz, Germany, D-55101, Germany
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Marburg, Germany, 35037, Germany
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München, Germany, 80331, Germany
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Teterow, Germany, 17166, Germany
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Bad Wörishofen, 86825, Germany
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Berlin, 10367, Germany
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Berlin, 12043, Germany
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Berlin, 12687, Germany
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Berlin, 13057, Germany
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Berlin, 13086, Germany
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Berlin, 13507, Germany
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Berlin, 13581, Germany
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Bonn, 53119, Germany
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Bonn, 53123, Germany
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Borstel, 23845, Germany
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Dachau, 85221, Germany
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Euskirchen, 53879, Germany
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Frankfurt, 60596, Germany
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Fürstenwalde, 15517, Germany
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Güstrow, 18273, Germany
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Hamburg, 20354, Germany
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Hamburg, 20357, Germany
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Hamburg, 22299, Germany
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Hamburg, 22305, Germany
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Hoyerswerda, 02977, Germany
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Landsberg, 86899, Germany
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München, 80335, Germany
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München, 80539, Germany
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München, 81243, Germany
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München, 81677, Germany
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Neu-Ulm, 89231, Germany
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Neumünster, 24534, Germany
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Neuss, 41462, Germany
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Oranienburg, 16515, Germany
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Radebeul, 01445, Germany
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Ratingen, 40878, Germany
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Rüdersdorf, 15562, Germany
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Ulm, 89081, Germany
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Wedel, 22880, Germany
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Witten, 58452, Germany
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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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Tatabánya, Hungary, 2800, Hungary
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Budapest, 1125, Hungary
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Deszk, 6772, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Nyíregyháza, 4400, Hungary
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Sopron, 9400, Hungary
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Törökbálint, 2045, Hungary
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Reykjavik, IS-109, Iceland
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Hyderabad, Andhra Pradesh, 500004, India
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Hyderabad, Andhra Pradesh, 500012, India
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Ahmedabad, Gujarat, 380009, India
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Ahmedabad, Gujrat-India, 380054, India
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Nagpur - Maharashtra, India, 440012, India
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Nagpur - Maharastra, India, 400 012, India
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Bangalore, Karnataka, 560 002, India
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Bangalore, Karnataka, 560002, India
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Mangalore, Karnataka, 575001, India
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Calicut, Kerala, 673008, India
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Trivandrum, Kerala, 695011, India
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Indore, Madhya Pradesh, 452001, India
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New Delhi, National Capital Territory of Delhi, 110029, India
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Noida, New Delhi, 201301, India
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Jaipur, Rajasthan, 302023, India
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Coimbatore, Tamil Nadu, 641 002, India
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Vellore, Tamil Nadu, 632004, India
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Panjim, 403002, India
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Ashkelon, 78278, Israel
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Jerusalem, 91120, 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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Acquaviva delle Fonti, BA, 70021, Italy
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Bari, BA, 70124, Italy
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Bergamo, BG, 24128, Italy
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Brescia, BS, 25127, Italy
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Catanzaro, CZ, 88100, Italy
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Cona, FE, 44100, Italy
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Cassino, FR, 03043, Italy
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Genova, GE, 16132, Italy
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Pisa, Italy, 56124, Italy
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Milan, MI, 20126, Italy
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Milan, MI, 20142, Italy
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Milan, MI, 20157, Italy
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Modena, MO, 41100, Italy
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Palermo, PA, 90146, Italy
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Pordenone, PN, 33170, Italy
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Prato, PO, 59100, Italy
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Parma, PR, 43100, Italy
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Roma, RM, 00133, Italy
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Roma, RM, 00161, Italy
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Roma, RM, 00163, Italy
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Roma, RM, 00168, Italy
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Cava de' Tirreni, SA, 84013, Italy
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Siena, SI, 53100, Italy
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Teramo, TE, 64100, Italy
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Orbassano, TO, 10043, Italy
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Trieste, TS, 34149, Italy
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Cuasso al Monte, VA, 21050, Italy
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Verona, VR, 37126, Italy
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Napoli, 80131, Italy
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Riga, LV, LV-1038, Latvia
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Riga, 1002, Latvia
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Kaunas, 44320, Lithuania
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Klaipėda, LT-92231, Lithuania
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Šiauliai, LT-76231, Lithuania
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Utena, LT-28151, Lithuania
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Vilnius, LT-08661, Lithuania
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Pachuca, Hidalgo, 42090, Mexico
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Guadalajara, Jalisco, 44100, Mexico
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Guadalajara, Jalisco, 44280, 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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Eindhoven, 5623 EJ, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Sneek, 8601 ZK, Netherlands
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Zwolle, 8011 JW, Netherlands
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Jesus Maria, Lima region, 11, Peru
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La Victoria, Lima region, 13, Peru
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Lima Cercado, Lima region, 01, Peru
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Miraflores, Lima region, 18, 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, 1104, Philippines
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Quezon City, National Capital Region, 1109, Philippines
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Quezon City, Philippines, 1101, Philippines
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Quezon City, 1100, Philippines
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Gdansk, 80-169, Poland
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Gdansk, 80-847, Poland
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Katowice, 40-752, Poland
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Krakow, 31-159, Poland
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Krakow, 31-202, Poland
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Krakow, 31-455, Poland
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Warsaw, 01-138, Poland
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Warsaw, 02-341, Poland
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Wroclaw, 50-044, Poland
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Amadora, 2720-276, Portugal
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Coimbra, 3000-075, Portugal
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Coimbra, 3041-853, Portugal
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Lisbon, 1169-024, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1769-001, Portugal
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Porto, 4200-319, Portugal
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Bucharest, District 3, 030303, Romania
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Brasov, Jud. Brasov, 500118, Romania
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Constanța, Jud. Constanta, 900002, Romania
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Iași, Jud. Iasi, 700115, Romania
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Bucharest, 060011, Romania
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Cluj-Napoca, 400371, Romania
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Kazan', Tatarstan Republic, 420015, Russia
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Chelyabinsk, 454021, Russia
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Chelyabinsk, 454047, Russia
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Kazan', 420015, Russia
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Moscow, 105077, Russia
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Moscow, 105229, Russia
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Moscow, 115280, Russia
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Moscow, 115446, Russia
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Moscow, 119992, Russia
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Moscow, 121359, Russia
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Moscow, 121609, Russia
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Saint Petersburg, 193231, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 197022, Russia
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Samara, 443079, Russia
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Yekaterinburg, 620109, Russia
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Yekaterinburg, 620219, Russia
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Bratislava, Slovak Republic, 821 06, Slovakia
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Košice, Slovak Republic, 041 90, Slovakia
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Spišská Nová Ves, Slovak Republic, 052 01, Slovakia
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Bratislava, 826 06, Slovakia
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Košice, 040 01, Slovakia
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Lučenec, 984 39, Slovakia
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Nové Zámky, 940 01, Slovakia
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Poprad, 058 01, Slovakia
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Durban, South Africa, 4001, South Africa
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Bloemfontein, 9301, South Africa
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Bloemfontein, 9317, South Africa
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Cape Town, 8001, South Africa
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Jerez de la Frontera, Andalusia, 11407, Spain
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Málaga, Andalusia, 29010, Spain
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Sanlúcar de Barrameda, Andalusia, 11540, Spain
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Seville, Andalusia, 41009, Spain
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Valladolid, Castille and León, 47011, Spain
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Illescas, Castille-La Mancha, 45200, Spain
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Barcelona, Catalonia, 08003, Spain
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Barcelona, Catalonia, 08036, Spain
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Barcelona, Catalonia, 08041, Spain
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Salt, Catalonia, 17190, Spain
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Sant Boi de Llobregat, Catalonia, 08830, Spain
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Terrassa, Catalonia, 08221, Spain
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Vic, Catalonia, 08500, Spain
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Skellefteå, Sweden, SE 931 32, Sweden
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Malmo, 205 02, Sweden
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Bern, 3013, Switzerland
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Lausanne, 1011, Switzerland
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Thun, 3600, Switzerland
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Related Publications (1)
Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D, McBryan D; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013 Sep;1(7):524-33. doi: 10.1016/S2213-2600(13)70158-9. Epub 2013 Aug 21.
PMID: 24461613DERIVED
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
February 15, 2009
First Posted
February 18, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 19, 2013
Results First Posted
November 19, 2013
Record last verified: 2013-09