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A Study of How MK0736 Affects Arterial Plaque

This study has been terminated.
Sponsor:
Collaborator:
FoxHollow Technologies
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00679055
First received: May 14, 2008
Last updated: August 5, 2008
Last verified: August 2008
History of Changes
  Purpose

A 12-Week Efficacy Study in patients with Peripheral Arterial Disease


Condition Intervention Phase
Peripheral Vascular Diseases
 Drug: MK0736
Drug: Comparator: placebo (unspecified)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Double-Blind, Placebo Controlled, Randomized, 12-Week Oral Dose Study to Evaluate the Effects of MK0736 on Atherosclerotic Disease Biomarkers in Lower Extremity Plaque Excised From Patients With Peripheral Arterial Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • To evaluate arterial plaque proteins [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate mRNA and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Patients will be administered once daily oral placebo at approximately the same time each morning for 12 weeks.
 Drug: Comparator: placebo (unspecified)
Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
Experimental: 2
Patients will be administered once daily oral MK0736 7mg at approximately the same time each morning for 12 weeks.
 Drug: MK0736
MK0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.
Other Name: MK0736

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679055

Sponsors and Collaborators
Merck
FoxHollow Technologies
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00679055     History of Changes
Other Study ID Numbers: 2007_600, MK0736-006
Study First Received: May 14, 2008
Last Updated: August 5, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013