The Effect of MK 0633 in Patients With Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00421278
First received: January 9, 2007
Last updated: July 30, 2009
Last verified: July 2009
  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:


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

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
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: NCT00421278

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 September 16, 2014