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

• ClinicalTrials.gov Identifier: NCT00679055
• Recruitment Status: Terminated
• First Posted: May 16, 2008
• Results First Posted: February 16, 2015
• Last Update Posted: August 17, 2018
• Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: FoxHollow Technologies
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Peripheral Vascular Diseases	Drug: MK-0736; Drug: Comparator: placebo (unspecified)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Actual Study Start Date: March 31, 2007
• Actual Primary Completion Date: August 26, 2008
• Actual Study Completion Date: August 26, 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: MK-0736; Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Drug: Comparator: placebo (unspecified); Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
Placebo Comparator: Placebo; Participants will be orally administered placebo once daily for 12 weeks.	Drug: MK-0736; MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Cluster of Differentiation 68 (CD68) [ Time Frame: Baseline and Week 12 ]
   CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.

Secondary Outcome Measures :

1. Change From Baseline in Messenger Ribonucleic Acid (mRNA) [ Time Frame: Baseline and Week 12 ]
   mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.
2. Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE) [ Time Frame: up to 14 weeks ]
   An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

FoxHollow Technologies

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Study Data/Documents: CSR Synopsis 

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00679055
• Other Study ID Numbers: 0736-006; 2007_600
• First Posted: May 16, 2008
• Results First Posted: February 16, 2015
• Last Update Posted: August 17, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases