Back to results

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

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MK0633

About this trial

This is an interventional diagnostic trial for Atherosclerosis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Arm 1: Drug

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00421278

First Posted

January 9, 2007

Last Updated

January 21, 2016

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00421278

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm 1: Drug

Intervention Type

Drug

Intervention Name(s)

MK0633

Intervention Description

Single dose MK0633 100mg po in the fed state administered during a 4-wk study.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs