Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD
Verified date | September 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Status | Completed |
Enrollment | 266 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening - Male or postmenopausal females 40 -75 years of age Exclusion Criteria: - Impaired renal function - History of chronic liver disease or persistent liver function test (LFT) abnormalities - History of recent cardiovascular clinical event - Evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary function test data | Measured over 12 weeks | No | |
Secondary | Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score | Measured over 12 weeks of treatment | No |
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