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

NCT00679055 | Terminated Phase 1 Results

• 2 other identifiers: 0736-0062007_600
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cluster of Differentiation 68 (CD68)

  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.

  Baseline and Week 12

Secondary Outcomes (2)

• Change From Baseline in Messenger Ribonucleic Acid (mRNA)

  Baseline and Week 12

• Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)

  up to 14 weeks

Study Arms (2)

MK-0736

EXPERIMENTAL

Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks

Drug: Comparator: placebo (unspecified)

Placebo

PLACEBO COMPARATOR

Participants will be orally administered placebo once daily for 12 weeks.

Drug: MK-0736

Interventions

MK-0736 DRUG

MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.

Placebo

Comparator: placebo (unspecified) DRUG

Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

MK-0736

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with peripheral arterial disease
• Participants must be 18 to 85 years of age
• Females must be postmenopausal or sterile

You may not qualify if:

• Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• FoxHollow Technologies: collaborator

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study terminated due to lack of recruitment.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: March 31, 2007
• Primary Completion: August 26, 2008
• Study Completion: August 26, 2008
• Last Updated: August 17, 2018
• Results First Posted: February 16, 2015

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share