A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
HZC102970: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
1,635
15 countries
183
Brief Summary
The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
183 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
September 25, 2009
CompletedFirst Submitted
Initial submission to the registry
November 19, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2011
CompletedResults Posted
Study results publicly available
August 19, 2013
CompletedAugust 31, 2018
August 1, 2018
2 years
November 19, 2009
May 30, 2013
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean
The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant \[par.\] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence \[color\]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.
From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Secondary Outcomes (3)
Time to First Occurrence of Moderate or Severe COPD Exacerbation
From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean
From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Change From Baseline in Trough FEV1 at Week 52 (Visit 11)
Baseline to Visit 11 (Week 52)/Early Withdrawal
Study Arms (4)
FF/GW642444 Inhalation Powder 100/25 mcg QD
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
FF/GW642444 Inhalation Powder 50mcg/25mcg QD
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
FF/GW642444 Inhalation Powder 200/25 mcg QD
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
GW642444 25mcg QD
EXPERIMENTALLong Acting Beta Agonist(LABA)
Interventions
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
Eligibility Criteria
You may qualify if:
- Type of subject: outpatient
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH \> 40MIU/ml and estradiol \<40pg/ml (\<140 pmol/L) is confirmatory. OR
- Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
- Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or
- Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
- Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
- Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or
- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
- Estrogenic vaginal ring; or
- Percutaneous contraceptive patches
- Age: ≥40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society \[Celli, 2004\]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- +5 more criteria
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
- α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
- Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 6 months preceding Screening (Visit 1), the subject will not be eligible for the study.
- Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myasthenia Gravis, etc).
- A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
- Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least ≥ 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
- Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (183)
GSK Investigational Site
Birmingham, Alabama, 35215, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Ozark, Alabama, 36360, United States
GSK Investigational Site
Tallassee, Alabama, 36078, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Phoenix, Arizona, 85023, United States
GSK Investigational Site
Tucson, Arizona, 85723, United States
GSK Investigational Site
Fresno, California, 93710, United States
GSK Investigational Site
Fresno, California, 93726, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Monterey Park, California, 91754, United States
GSK Investigational Site
National City, California, 91950, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
San Diego, California, 92128, United States
GSK Investigational Site
Torrance, California, 90502, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Van Nuys, California, 91405, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Thornton, Colorado, 80233, United States
GSK Investigational Site
Hartford, Connecticut, 06105, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Kissimmee, Florida, 34741, United States
GSK Investigational Site
Miami, Florida, 33183, United States
GSK Investigational Site
Pensacola, Florida, 32503, United States
GSK Investigational Site
St. Petersburg, Florida, 33707, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Gainesville, Georgia, United States
GSK Investigational Site
Martinez, Georgia, 30907, United States
GSK Investigational Site
Riverdale, Georgia, 30274, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Aurora, Illinois, 60504, United States
GSK Investigational Site
Elk Grove Village, Illinois, 60007, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Council Bluffs, Iowa, 51503, United States
GSK Investigational Site
Olathe, Kansas, 66061, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Hazard, Kentucky, 41701, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Brockton, Massachusetts, 02301, United States
GSK Investigational Site
Fall River, Massachusetts, 02720, United States
GSK Investigational Site
Pittsfield, Massachusetts, 01201, United States
GSK Investigational Site
Cadillac, Michigan, 49601, United States
GSK Investigational Site
Edina, Minnesota, 55438, United States
GSK Investigational Site
Fridley, Minnesota, 55432, United States
GSK Investigational Site
Columbia, Missouri, 65212, United States
GSK Investigational Site
Springfield, Missouri, 65803, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
St Louis, Missouri, 63143, United States
GSK Investigational Site
Lincoln, Nebraska, 68506, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Papillion, Nebraska, 68046, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Cherry Hill, New Jersey, 08003, United States
GSK Investigational Site
Summit, New Jersey, 07091, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
North Syracuse, New York, 13212, United States
GSK Investigational Site
Asheville, North Carolina, 28803, United States
GSK Investigational Site
Burlington, North Carolina, 27215, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Centerville, Ohio, 45459, United States
GSK Investigational Site
Toledo, Ohio, 43614, United States
GSK Investigational Site
Portland, Oregon, 97220, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Murrells Inlet, South Carolina, 29576, United States
GSK Investigational Site
Pelzer, South Carolina, 29669, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Nashville, Tennessee, 37232, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
New Braunfels, Texas, 78130, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Wichita Falls, Texas, 76309, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Madison, Wisconsin, 53715, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH, Argentina
GSK Investigational Site
Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000DGF, Argentina
GSK Investigational Site
Kingswood, New South Wales, 2747, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Auchenflower, Queensland, 4066, Australia
GSK Investigational Site
Southport, Queensland, 4215, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Hobart, Tasmania, 7000, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Grimsby, Ontario, L3M 1P3, Canada
GSK Investigational Site
Hamilton, Ontario, L8M 1K7, Canada
GSK Investigational Site
London, Ontario, N5W 6A2, Canada
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Toronto, Ontario, M5G 1N8, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Montreal, Quebec, H2X 2P4, Canada
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500691, Chile
GSK Investigational Site
Talcahuano, 4270918, Chile
GSK Investigational Site
Aalborg, 9100, Denmark
GSK Investigational Site
Aarhus C, 8000, Denmark
GSK Investigational Site
Hvidovre, 2650, Denmark
GSK Investigational Site
København NV, 2400, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Kassel, Hesse, 34121, Germany
GSK Investigational Site
Marburg, Hesse, 35037, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65183, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30167, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Hamburg, 20354, Germany
GSK Investigational Site
Foggia, Apulia, 71100, Italy
GSK Investigational Site
Salerno, Campania, 84100, Italy
GSK Investigational Site
San Felice A Cancello Caserta, Campania, 81027, Italy
GSK Investigational Site
Modena, Emilia-Romagna, 41124, Italy
GSK Investigational Site
Parma, Emilia-Romagna, 43100, Italy
GSK Investigational Site
Rome, Lazio, 00168, Italy
GSK Investigational Site
Palermo, Sicily, 90146, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Perugia, Umbria, 06156, Italy
GSK Investigational Site
Guadalajara, Jalisco, 44600, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64460, Mexico
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Almere Stad, 1315 RA, Netherlands
GSK Investigational Site
Beek, 6191 JW, Netherlands
GSK Investigational Site
Breda, 4819 EV, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Groningen, 9728 NP, Netherlands
GSK Investigational Site
Hoorn, 1624 NP, Netherlands
GSK Investigational Site
Horn, 6085 NM, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Zutphen, 7207 AE, Netherlands
GSK Investigational Site
Lima, Lima Province, Peru
GSK Investigational Site
San Miguel, Lima region, Lima 32, Peru
GSK Investigational Site
Santiago de Surco, Lima region, Lima 33, Peru
GSK Investigational Site
Callao, Callao 2, Peru
GSK Investigational Site
Meyerspark, Gauteng, 0184, South Africa
GSK Investigational Site
Parktown, Gauteng, 2193, South Africa
GSK Investigational Site
Waterkloof Ridge, Gauteng, 0181, South Africa
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Cape Town, 7572, South Africa
GSK Investigational Site
Gatesville, 7764, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Roodepoort, 1724, South Africa
GSK Investigational Site
Worcester, 6850, South Africa
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Cartagena (Murcia), 30202, Spain
GSK Investigational Site
Cáceres, 10003, Spain
GSK Investigational Site
Elda, 03600, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Orihuela/Alicante, 03314, Spain
GSK Investigational Site
Pama de Mallorca, 07010, Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223, Spain
GSK Investigational Site
Åtvidaberg, SE-597 26, Sweden
GSK Investigational Site
Bankeryd, SE-564 31, Sweden
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Lidingö, SE-181 58, Sweden
GSK Investigational Site
Southampton, Hampshire, SO16 6YD, United Kingdom
GSK Investigational Site
Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom
GSK Investigational Site
Trowbridge, Wiltshire, BA14 8QA, United Kingdom
GSK Investigational Site
Cambridge, CB2 0QQ, United Kingdom
GSK Investigational Site
Chertsey, Surrey, KT16 0PZ, United Kingdom
GSK Investigational Site
Wythenshawe, Manchester, M23 9LT, United Kingdom
Related Publications (5)
Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12.
PMID: 24429127BACKGROUNDLargajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.
PMID: 31197640DERIVEDHinds DR, DiSantostefano RL, Le HV, Pascoe S. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open. 2016 Jun 1;6(6):e010099. doi: 10.1136/bmjopen-2015-010099.
PMID: 27251682DERIVEDCrim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Lettis S, Calverley PM. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27-34. doi: 10.1513/AnnalsATS.201409-413OC.
PMID: 25490706DERIVEDSvedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.
PMID: 24314123DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2009
First Posted
November 23, 2009
Study Start
September 25, 2009
Primary Completion
October 1, 2011
Study Completion
October 17, 2011
Last Updated
August 31, 2018
Results First Posted
August 19, 2013
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.