Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

NCT01543919 | Completed Phase 2 DMC

• 1 other identifier: A6631033
• Study Type: interventional
• Target: 730
• Locations: 14 countries
• Sites: 132

Brief Summary

PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12.

  Baseline, week 12

Secondary Outcomes (13)

• Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume1 at Weeks 2, 6, and 10

  Baseline, week 2, 6, and 10

• Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume6 at Weeks 2, 6, 10 and 12

  Baseline, week 2, 6, 10 and 12

• Change from baseline in trough, pre-bronchodilator Forced Vital Capacity at Weeks 2, 6, 10 and 12

  Baseline, week 2, 6, 10 and 12

• Change from baseline in trough, pre-bronchodilator Inspiratory Capacity at Weeks 2, 6, 10 and 12

  Baseline, week 2, 6, 10 and 12

• Average change from baseline in trough, pre-bronchodilator Forced Expiratory Volume 1, Forced Expiratory Volume 6, Forced Vital Capacity and Inspiratory Capacity over 12 weeks treatment

  Baseline, week 12

Study Arms (6)

PH-787904 (arm1)

EXPERIMENTAL

Drug: PH-797804

PH-787904 (arm2)

EXPERIMENTAL

Drug: PH-797804

PH-787904 (arm3)

EXPERIMENTAL

Drug: PH-797804

PH-787904 (arm4)

EXPERIMENTAL

Drug: PH-797804

PH-787904 (arm5)

EXPERIMENTAL

Drug: PH-797804

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

PH-797804 DRUG

0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

PH-787904 (arm1)

Placebo DRUG

Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between, and including, the ages of 40 and 80 years.
• Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: Subjects must have a post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel ECCS standards or NHANES III standards.
• Subjects must have a smoking history of at least 10 pack-years\* and meet one of the following criteria: They are current smokers, or they are ex-smokers who have abstained from smoking for at least 6 months.
• Subjects treated with tiotropium bromide (SPIRIVA HandiHaler) 18 microgram daily for at least 1 month prior to screening.
• Subjects must have had stable disease for at least 1 month prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately with tiotropium bromide +/- salbutamol (albuterol) rescue medication (subjects should not use \>10 actuations \[100 microgram/actuations\] daily for more than 2 consecutive days), without reliance on other therapies including oral or inhaled corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline, roflumilast or regular oxygen.

You may not qualify if:

• A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
• History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
• History or presence of respiratory failure, cor pulmonale or right ventricular failure.
• Subjects with home oxygen therapy (either PRN or long-term oxygen therapy).
• Any clearly documented history of adult asthma or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
• Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is not required).
• History of cancer (other than cutaneous basal cell) in the previous 5 years.
• Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive esophagitis, gastric outlet obstruction or inflammatory bowel disease.
• Regular use of aspirin at a dose greater than 325 mg/day.
• History within the previous 6 months of: myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
• A family history of long QT syndrome.
• Presenting with: Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
• Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0.
• Any clinically significant active systemic or cutaneous infection including herpetic lesions.
• Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (132)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35294, United States

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Jasper, Alabama, 35501, United States

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Phoenix, Arizona, 85006, United States

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Montclair, California, 91763, United States

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San Diego, California, 92120, United States

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Waterbury, Connecticut, 06708, United States

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Newark, Delaware, 19713, United States

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Brandon, Florida, 33511, United States

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Chiefland, Florida, 32226, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33765, United States

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New Port Richey, Florida, 34653, United States

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Pensacola, Florida, 32504, United States

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Tampa, Florida, 33603, United States

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Williston, Florida, 32696, United States

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Duluth, Georgia, 30096, United States

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Fort Mitchell, Kentucky, 41017, United States

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Lexington, Kentucky, 40504, United States

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Baltimore, Maryland, 21224, United States

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Edina, Minnesota, 55435, United States

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Fridley, Minnesota, 55432, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63141, United States

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Albuquerque, New Mexico, 87108, United States

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Albuquerque, New Mexico, 87109, United States

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Albuquerque, New Mexico, 87110, United States

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28207, United States

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Cincinnati, Ohio, 45231, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45245, United States

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Oklahoma City, Oklahoma, 73112, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pawtucket, Rhode Island, 02860, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29414, United States

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Kingsport, Tennessee, 37660, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78212, United States

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Midvale, Utah, 84047, United States

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Buenos Aires, 1426, Argentina

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Rousse, 7002, Bulgaria

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Sevlievo, 5400, Bulgaria

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Sofia, 1000, Bulgaria

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Sofia, 1431, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Troyan Municipality, 5600, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Winnipeg, Manitoba, R2K 3S8, 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, H4N 3C5, Canada

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Québec, Quebec, G3K 2P8, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Karlovy Vary, 36009, Czechia

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Liberec, 460 01, Czechia

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Mělník, 27601, Czechia

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Prague, 108 00, Czechia

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Prague, 153 00, Czechia

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Rokycany, 337 22, Czechia

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Teplice, 41501, Czechia

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Berlin, 10117, Germany

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Berlin, 13125, Germany

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Dresden, 01069, Germany

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Gelnhausen, 63571, Germany

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Großhansdorf, 22927, Germany

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Hamburg, 20253, Germany

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Hamburg, 20354, Germany

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Hanover, 30159, Germany

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Kassel, 34121, Germany

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Lübeck, 23552, Germany

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Schwerin, 19055, Germany

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Balassagyarmat, 2660, Hungary

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Budaörs, 2040, Hungary

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Budapest, 1122, Hungary

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Debrecen, 4032, Hungary

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Szeged, 6722, Hungary

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Szombathely, 9700, Hungary

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Törökbálint, 2045, Hungary

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Nagoya, Aichi-ken, Japan

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Seto-shi, Aichi-ken, Japan

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Toyota, Aichi-ken, Japan

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Noda, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Yanagawa, Fukuoka, Japan

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Kanazawa, Ishikawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Kawasaki-shi, Kanagawa, Japan

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Zama, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Saiki, Oita Prefecture, Japan

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Osaka, Osaka, Japan

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Meguro-ku, Tokyo, Japan

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Setagaya City, Tokyo, Japan

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Warsaw, 04-141, Poland

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Wroclaw, 53-301, Poland

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Wroclaw, 54-239, Poland

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Bardejov, 085 01, Slovakia

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Bojnice, 972 01, Slovakia

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Bratislava, 826 06, Slovakia

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Bratislava, 841 04, Slovakia

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Humenné, 066 01, Slovakia

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Košice, 040 01, Slovakia

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Liptovský Hrádok, 033 01, Slovakia

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Námestovo, 029 01, Slovakia

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Poprad, 058 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Štúrovo, 943 01, Slovakia

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Bloemfontein, Free State, 9301, South Africa

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Gatesville, Western Cape, 7764, South Africa

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Parow, Western Cape, 7505, South Africa

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Cape Town, 7500, South Africa

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Cape Town, 7530, South Africa

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Durban, 4001, South Africa

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Durban, 4126, South Africa

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Pretoria, 0181, South Africa

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Petrel, Alicante, 03610, Spain

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Mérida, Badajoz, 06800, Spain

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Salt, Girona, 17190, Spain

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Pozuelo de Alarcón, Madrid, 28223, Spain

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Gothenburg, 412 63, Sweden

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Linköping, 58216, Sweden

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Lund, 22185, Sweden

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Malmo, 211 52, Sweden

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Skene, 511 62, Sweden

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Taipei, 100, Taiwan

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

PH 797804

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 28, 2012
• First Posted: March 5, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 27, 2014

Record last verified: 2014-09

Locations

DE (11); PL (3); SE (5); TW (1); SL (11); HU (7); CZ (7); ES (4); AR (1); ZA (8); US (45); CA (7); BU (7); JP (15)