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

January 21, 2016 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Efficacy and Safety of MK0633 in Patients With Atherosclerosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Arm 1: Drug
Drug: MK0633
Single dose MK0633 100mg po in the fed state administered during a 4-wk study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0633-008
  • MK0633-008
  • 2006_563

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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