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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: MK0633
  • Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633
• Drug: Comparator: placebo
  • Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • MK0633 10 mg
• Experimental: 2
  • MK0633 50 mg
• Experimental: 3
  • MK0633 100 mg
• Placebo Comparator: 4
  • placebo

Primary Measures

• Pulmonary function test data measured over 6 weeks
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks
  • Time Frame: 6 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404313

Study ID Number: 2006_553

ClinicalTrials.gov Identifier: NCT00404313

Health Authority: United States: Food and Drug Administration