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

Tracking Information

First Received Date ^ICMJE

May 14, 2008

Last Updated Date

August 5, 2008

Start Date ^ICMJE

May 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00679055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of How MK0736 Affects Arterial Plaque

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Peripheral Vascular Diseases

Intervention ^ICMJE

Drug: MK0736
MK0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.

Other Name: MK0736
Drug: Comparator: placebo (unspecified)
Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

Study Arm (s)

Placebo Comparator: 1
Patients will be administered once daily oral placebo at approximately the same time each morning for 12 weeks.

Intervention: Drug: Comparator: placebo (unspecified)
Experimental: 2
Patients will be administered once daily oral MK0736 7mg at approximately the same time each morning for 12 weeks.

Intervention: Drug: MK0736

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00679055

Other Study ID Numbers ^ICMJE

2007_600, MK0736-006

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

FoxHollow Technologies

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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