A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Peripheral Vascular Diseases

Treatments: Drug: MK-0736; Drug: Comparator: placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00679055

0736-006

2007_600

Details and patient eligibility

About

A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).

Enrollment: 14 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with peripheral arterial disease
• Participants must be 18 to 85 years of age
• Females must be postmenopausal or sterile

Exclusion criteria

• Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

MK-0736

Experimental group

Description:

Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks

Treatment:

Drug: Comparator: placebo (unspecified)

Placebo

Placebo Comparator group

Description:

Participants will be orally administered placebo once daily for 12 weeks.

Treatment:

Drug: MK-0736