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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00418613
First received: January 3, 2007
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: MK633
Drug: Comparator: Placebo (unspecified)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pulmonary function test data [ Time Frame: Measured over 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score [ Time Frame: Measured over 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0633
Drug: MK633
MK0633 100mg capsules qd for a 12-wk treatment period.
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo (unspecified)
MK0633 100mg Pbo capsules for a 12-wk treatment period

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418613

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00418613     History of Changes
Other Study ID Numbers: 0633-009, MK0633-009, 2006_509
Study First Received: January 3, 2007
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014