MedDataX Logo

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

NCT ID: NCT00679055

Last Updated: 2018-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis

NCT01666704

Atherosclerotic Cardiovascular Disease
WITHDRAWN PHASE2

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

NCT06212271

Peripheral Artery Disease
RECRUITING EARLY_PHASE1

The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina

NCT01763996

Coronary Artery Disease
COMPLETED PHASE4

A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS

NCT06413693

Healthy Participants
COMPLETED PHASE1

Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

NCT00636766

Carotid Atherosclerosis Stroke Type 2 Diabetes +1 more
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MK-0736

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

Group Type EXPERIMENTAL

Comparator: placebo (unspecified)

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

MK-0736

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MK-0736

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

Intervention Type DRUG

Comparator: placebo (unspecified)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

FoxHollow Technologies

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: CSR Synopsis

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007_600

Identifier Type: -

Identifier Source: secondary_id

0736-006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
NCT07223593 RECRUITING PHASE3
Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients
NCT00751608 WITHDRAWN PHASE2
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
NCT04848220 TERMINATED PHASE2
ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation
NCT01067820 COMPLETED PHASE2
Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease
NCT03247972 TERMINATED
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease
NCT06342609 COMPLETED PHASE4
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
NCT03626662 COMPLETED PHASE1
Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC
NCT03683628 UNKNOWN NA
MDCO-216 Infusions Leading to Changes in Atherosclerosis: A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound (IVUS), Lipids, and Other Surrogate Biomarkers Trial
NCT02678923 COMPLETED PHASE1/PHASE2
Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
NCT03194776 COMPLETED PHASE2
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
NCT03469349 COMPLETED PHASE3
Biological Response to Platelet-rich Plasma and Corticosteroid Injections
NCT05657496 TERMINATED PHASE1/PHASE2
Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism
NCT03773172 TERMINATED PHASE2
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
NCT01813422 COMPLETED PHASE3
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers
NCT02057835 COMPLETED PHASE1
Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II
NCT05764356 NOT_YET_RECRUITING
Treatment of Patients With Atherosclerotic Disease With Methotrexate-associated to LDL Like Nanoparticles
NCT04616872 UNKNOWN PHASE2/PHASE3
Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
NCT07303777 NOT_YET_RECRUITING PHASE2
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
NCT00382213 COMPLETED PHASE3
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
NCT00443287 COMPLETED PHASE2
Investigation of Plaque Instability Using Bevacizumab-800CW and MSOT
NCT03757507 UNKNOWN NA
SB-659032 Platelet Aggregation Study
NCT01745458 COMPLETED PHASE1
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
NCT01764633 COMPLETED PHASE3
Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest
NCT03149406 UNKNOWN
Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)
NCT03297814 UNKNOWN PHASE1/PHASE2