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The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421278
First Posted: January 11, 2007
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421278


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00421278     History of Changes
Other Study ID Numbers: 0633-008
MK0633-008
2006_563
First Submitted: January 9, 2007
First Posted: January 11, 2007
Last Update Posted: January 22, 2016
Last Verified: January 2016

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