Peripheral Vascular DiseasesPhase 1NCT00679055

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

A Phase 1 study testing MK-0736 in people with Peripheral Vascular Diseases, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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). Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Peripheral Vascular Diseases
What is being tested?: MK-0736
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: No sites listed yet
Study dates: 31 Mar 2007to 26 Aug 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Peripheral Vascular Diseases
Being tested: MK-0736, Comparator: placebo (unspecified)
Medical subject headings: Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0736Drug
MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.
Comparator: placebo (unspecified)Drug
Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

Study groups in NCT00679055
Study group	Role	What they receive
MK-0736	Experimental	Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks Receives: Drug: Comparator: placebo (unspecified)
Placebo	Placebo comparator	Participants will be orally administered placebo once daily for 12 weeks. Receives: Drug: MK-0736

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 12

Secondary outcomes (2)

Change From Baseline in Messenger Ribonucleic Acid (mRNA)
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.
Measured: Baseline and Week 12
Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)
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.
Measured: up to 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 200726 Aug 2008

First posted16 May 2008 (estimated)
Study start31 Mar 2007
Primary completion26 Aug 2008
Study completion26 Aug 2008

Why it stopped: Lack of recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00679055
Sponsor's protocol ID: 0736-006
Other IDs: 2007_600
Status last verified: Jul 2018
First submitted: 14 May 2008
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingObservational study
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Peripheral Vascular Diseases

All Peripheral Vascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00679055
Acronym / sponsor ID: 0736-006
Conditions: Peripheral Vascular Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of recruitment
Enrolment: 14 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: FoxHollow Technologies
Study start: 31 Mar 2007 (actual)
Primary completion: 26 Aug 2008 (actual)
Study completion: 26 Aug 2008 (actual)
First posted: 16 May 2008 (estimated)
Results: Posted 16 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MK-0736	Experimental	Drug: Comparator: placebo (unspecified)Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
Placebo	Placebo comparator	Drug: MK-0736Participants will be orally administered placebo once daily for 12 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-0736MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.	Drug	Placebo
Comparator: placebo (unspecified)Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.	Drug	MK-0736

Primary outcome

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.

2 secondary outcomes

Change From Baseline in Messenger Ribonucleic Acid (mRNA)
Time frame: Baseline and Week 12
Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)
Time frame: up to 14 weeks

Results and safety

Results posted to the registry on 16 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-0736	8	6
Placebo	6	1

Primary outcome: Change From Baseline in Cluster of Differentiation 68 (CD68)

Time frame: Baseline and Week 12

Population analysed: Study terminated early. Planned analyses was not performed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0736	1 of 8 (12.5%)	5 of 8 (62.5%)	Not reported
Placebo	1 of 6 (16.7%)	4 of 6 (66.7%)	Not reported

Limitations and caveats (from the sponsor): Study terminated due to lack of recruitment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Peripheral Vascular Diseases

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingObservational study
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Peripheral Vascular Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-0736 in people with Peripheral Vascular Diseases, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cluster of Differentiation 68 (CD68) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.