Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of How MK0736 Affects Arterial Plaque

This study has been terminated.
Sponsor:
Collaborator:
FoxHollow Technologies
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00679055
First received: May 14, 2008
Last updated: August 5, 2008
Last verified: August 2008
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679055

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
FoxHollow Technologies
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014