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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418613
• Other study ID #: 0633-009
• Secondary ID: MK0633-0092006_5
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: September 2, 2015
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• MK633
MK0633 100mg capsules qd for a 12-wk treatment period.
• Comparator: Placebo (unspecified)
MK0633 100mg Pbo capsules for a 12-wk treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test data		Measured over 12 weeks	No
Secondary	Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score		Measured over 12 weeks of treatment	No