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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421278
• Other study ID #: 0633-008
• Secondary ID: MK0633-0082006_5
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2007
• Last updated: January 21, 2016
• Start date: November 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 Weeks	No