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

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ClinicalTrials.gov Identifier: NCT00679055
Recruitment Status : Terminated (Lack of recruitment)
First Posted : May 16, 2008
Results First Posted : February 16, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
FoxHollow Technologies
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679055


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
FoxHollow Technologies
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00679055     History of Changes
Other Study ID Numbers: 0736-006
2007_600
First Posted: May 16, 2008    Key Record Dates
Results First Posted: February 16, 2015
Last Update Posted: May 3, 2017
Last Verified: March 2017

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