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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00418613
Enrollment
266
Registered
2007-01-05
Start date
2008-01-31
Completion date
2009-03-31
Last updated
2015-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

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

Interventions

DRUGMK633

MK0633 100mg capsules qd for a 12-wk treatment period.

DRUGComparator: Placebo (unspecified)

MK0633 100mg Pbo capsules for a 12-wk treatment period

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pulmonary function test dataMeasured over 12 weeks

Secondary

MeasureTime frame
Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) scoreMeasured over 12 weeks of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026