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Clinical Trials/NCT00404313
NCT00404313TerminatedPhase 2

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma

Merck Sharp & Dohme LLC0 sites688 target enrollmentStarted: January 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
688
Primary Endpoint
Pulmonary function test data measured over 6 weeks

Study Overview

Brief Summary

A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production
  • Males and females 18-70 years of age

Exclusion Criteria

  • History of kidney or chronic liver disease
  • Recent history of heart problems within the past 3 months
  • Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD

Arms & Interventions

1

Experimental

MK0633 10 mg

Intervention: MK0633 (Drug)

2

Experimental

MK0633 50 mg

Intervention: MK0633 (Drug)

3

Experimental

MK0633 100 mg

Intervention: MK0633 (Drug)

Outcomes

Primary Outcomes

Pulmonary function test data measured over 6 weeks

Time Frame: 6 weeks

Secondary Outcomes

  • Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks(6 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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