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: August 2008

Intervention(s) in this Clinical Trial

• Drug: MK0633
  • MK0633 5mg po qd w/ 240 mL of water. Treatment duration is 6 weeks.
• Drug: Comparator: Diltiazem
  • 240mg Diltiazem po qd for 14 days w/ 240 mL of water. Treatment duration is 6 weeks.
• Drug: Comparator: Placebo (unspecified)
  • MK0633 5mg Pbo po qd w/ 240 mL of water. Treatment duration is 6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1A & 1B
  • Arm 1A: MK0633 (fasted state); Arm 1B: MK0633 (fed state). MK0633 5mg po (or matching Pbo) qd in the fasted state w/ 240 mL of water; MK0633 5mg po (or matching Pbo) qd in the fed state w/ 240 mL of water. Treatment duration is 6 weeks.
• Other: 2
  • Arm 2: Open label Diltiazem + MK0633. 240mg Diltiazem po qd for 14 days w/ 240 mL of water + single dose of MK0663 5mg po coadministered in the fasted state on day 7. Treatment duration is 6 weeks.

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 18-65 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: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on September 05, 2008

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