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The Effect of MK 0633 in Patients With Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00421278
First received: January 9, 2007
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease


Condition Intervention Phase
Atherosclerosis
 Drug: MK0633
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Clinical Study to Evaluate the Efficacy and Safety of MK0633 in Patients With Atherosclerosis

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: November 2006
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: Drug
 Drug: MK0633
Single dose MK0633 100mg po in the fed state administered during a 4-wk study.
Other Name: MK0633

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease
  • Inflammatory marker found in your blood, known as hsCRP > 0.5 mg/L

Exclusion Criteria:

  • Age < 40 or > 85
  • Female
  • Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months
  • Liver diseased or abnormalities
  • HIV infection
  • Lupus, rheumatoid arthritis, cancer <5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421278

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00421278     History of Changes
Other Study ID Numbers: 2006_563, MK0633-008
Study First Received: January 9, 2007
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013