A Study of How MK0736 Affects Arterial Plaque - Full Text View

Sponsor:	Merck
Collaborator:	FoxHollow Technologies
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00679055

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
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:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

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
1: Placebo Comparator 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.
2: Experimental 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.

Eligibility

Criteria

Inclusion Criteria:

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

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2010