A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: MK633

• Registration Number: NCT00418613
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-03
• Study First Posted: 2007-01-05
• Study Start: 2008-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MK633	MK0633

Primary Outcome Measures

Name	Time	Method
Pulmonary function test data	Measured over 12 weeks

Secondary Outcome Measures

Name	Time	Method
Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score	Measured over 12 weeks of treatment