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Clinical Trials/NCT00418613
NCT00418613
Completed
Phase 2

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD

Merck Sharp & Dohme LLC0 sites266 target enrollmentJanuary 2008
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ConditionsChronic Obstructive Pulmonary Disease (COPD)
InterventionsMK633
DrugsMK633Comparator: Placebo (unspecified)

Overview

Phase
Phase 2
Intervention
MK633
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Merck Sharp & Dohme LLC
Enrollment
266
Primary Endpoint
Pulmonary function test data
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
March 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

1

MK0633

Intervention: MK633

Outcomes

Primary Outcomes

Pulmonary function test data

Time Frame: Measured over 12 weeks

Secondary Outcomes

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

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