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

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborator:
FoxHollow Technologies
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00679055
First received: May 14, 2008
Last updated: April 5, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Peripheral Vascular Diseases
Drug: MK-0736
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:
  • Change From Baseline in Cluster of Differentiation 68 (CD68) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Messenger Ribonucleic Acid (mRNA) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE) [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 14
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00679055     History of Changes
Other Study ID Numbers: 0736-006  2007_600 
Study First Received: May 14, 2008
Results First Received: January 30, 2015
Last Updated: April 5, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 21, 2016