Back to resultsA Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0359
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- You are between the ages of 40 and 75
- You have had a history for at least a year of COPD symptoms
- You have a history of smoking one pack of cigarettes per day for 10 years
Exclusion Criteria:
- You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
- You have donated blood in the last 4 weeks.
- You have been hospitalized or had major surgery in the last 4 weeks
- You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
- You have a history of heart problems in the last 6 months
- You have a history of stomach problems
- You are unwilling to avoid grapefruit juice throughout the study
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00482235
First Posted
June 1, 2007
Last Updated
November 30, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00482235
Brief Title
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0359
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You are between the ages of 40 and 75
You have had a history for at least a year of COPD symptoms
You have a history of smoking one pack of cigarettes per day for 10 years
Exclusion Criteria:
You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
You have donated blood in the last 4 weeks.
You have been hospitalized or had major surgery in the last 4 weeks
You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
You have a history of heart problems in the last 6 months
You have a history of stomach problems
You are unwilling to avoid grapefruit juice throughout the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19135348
Citation
Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8.
Results Reference
result
Learn more about this trial
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
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