Primary HypercholesterolemiaPhase 1NCT01012219

A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)

A Phase 1 study testing niacin (+) laropiprant, Comparator: aspirin and Comparator: clopidogrel in people with Primary Hypercholesterolemia and Mixed Hyperlipidemia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Hypercholesterolemia, Mixed Hyperlipidemia
What is being tested?: niacin (+) laropiprant, Comparator: aspirin and Comparator: clopidogrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: No sites listed yet
Study dates: Nov 2009to Apr 2010
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)
Participant is a non-smoker

Who cannot join

Participant has a history of chronic seizures
Participant has a history of cancer
Participant has a history of stomach or intestinal ulcers or any history of GI bleeding
Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

About this study

Official title: A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination and to Evaluate Single Dose Pharmacokinetics of MK0524A in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia

Conditions: Primary Hypercholesterolemia, Mixed Hyperlipidemia
Being tested: niacin (+) laropiprant, Comparator: aspirin, Comparator: clopidogrel, Comparator: laropiprant, Comparator: placebo
Medical subject headings: Hyperlipoproteinemia Type II

What participants receive

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

niacin (+) laropiprantDrug
Also called Tredaptive
open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
Comparator: aspirinDrug
81 mg oral tablet once daily for 7 days
Comparator: clopidogrelDrug
75 mg oral tablet once daily for 7 days
Comparator: laropiprantDrug
40 mg oral tablet once daily for 7 days
Comparator: placeboDrug
placebo oral tablet once daily for 7 days

Study groups in NCT01012219
Study group	Role	What they receive
Period 1	Experimental	In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). Receives: Drug: Comparator: aspirin; Drug: Comparator: clopidogrel; Drug: Comparator: laropiprant; Drug: Comparator: placebo
Period 2	Experimental	In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). Receives: Drug: Comparator: aspirin; Drug: Comparator: clopidogrel; Drug: Comparator: laropiprant; Drug: Comparator: placebo
Period 3	Experimental	Not described Receives: Drug: niacin (+) laropiprant

What is being measured

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

Cutaneous Bleeding Time (BT)
Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.
The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.
Period 3 was not analyzed as bleeding time was not an objective for this part of the study.
Measured: Day 8

Timeline

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

Nov 2009Apr 2010

First posted11 Nov 2009 (estimated)
Study startNov 2009
Primary completionMar 2010
Study completionApr 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary HypercholesterolemiaStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01012219
Sponsor's protocol ID: 0524A-114
Other IDs: 2009_689
Status last verified: Oct 2015
First submitted: 10 Nov 2009
Last updated: 2 Nov 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

De Kam PJ, Luo WL, Wenning L, Ratcliffe L, Sisk CM, Royalty J, Radziszewski W, Wagner JA, Lai E. The effects of laropiprant on the antiplatelet activity of co-administered clopidogrel and aspirin. Platelets. 2014;25(7):480-7. doi: 10.3109/09537104.2013.836747. Epub 2013 Nov 8.
PubMed 24206527

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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
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RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination and to Evaluate Single Dose Pharmacokinetics of MK0524A in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia
ClinicalTrials.gov ID: NCT01012219
Acronym / sponsor ID: 0524A-114
Conditions: Primary Hypercholesterolemia, Mixed Hyperlipidemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Mar 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 11 Nov 2009 (estimated)
Results: Posted 18 Apr 2011

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Period 1	Experimental	Drug: Comparator: aspirin, Drug: Comparator: clopidogrel, Drug: Comparator: laropiprant, Drug: Comparator: placeboIn Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days).
Period 2	Experimental	Drug: Comparator: aspirin, Drug: Comparator: clopidogrel, Drug: Comparator: laropiprant, Drug: Comparator: placeboIn Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days).
Period 3	Experimental	Drug: niacin (+) laropiprant

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)
Participant is a non-smoker

Key exclusion criteria (4 listed)

Participant has a history of chronic seizures
Participant has a history of cancer
Participant has a history of stomach or intestinal ulcers or any history of GI bleeding
Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

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
niacin (+) laropiprantAlso: Tredaptiveopen-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets	Drug	Period 3
Comparator: aspirin81 mg oral tablet once daily for 7 days	Drug	Period 1, Period 2
Comparator: clopidogrel75 mg oral tablet once daily for 7 days	Drug	Period 1, Period 2
Comparator: laropiprant40 mg oral tablet once daily for 7 days	Drug	Period 1, Period 2
Comparator: placeboplacebo oral tablet once daily for 7 days	Drug	Period 1, Period 2

Primary outcome

Cutaneous Bleeding Time (BT)
Time frame: Day 8
Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days. The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable. Period 3 was not analyzed as bleeding time was not an objective for this part of the study.

Results and safety

Results posted to the registry on 18 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	36	35

Primary outcome: Cutaneous Bleeding Time (BT)

Time frame: Day 8. Least squares mean (95% Confidence Interval). Unit: Seconds

Measure	Clopidogrel + Aspirin +Laropiprant n = 34	Clopidogrel + Aspirin n = 33
Value	478 (381 to 599)	389 (309 to 490)

Clopidogrel + Aspirin +Laropiprant vs Clopidogrel + Aspirin: Geometric least-squares mean ratio: 1.23 (90% CI 0.96 to 1.56)

Population analysed: Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laropiprant + Clopidrogel + Aspirin	0 of 36 (0%)	24 of 36 (66.7%)	Not reported
Clopidogrel + Aspirin	0 of 36 (0%)	23 of 36 (63.9%)	Not reported
Laropiprant + Niacin	0 of 20 (0%)	20 of 20 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24206527De Kam PJ, Luo WL, Wenning L, Ratcliffe L, Sisk CM, Royalty J, Radziszewski W, Wagner JA, Lai E. The effects of laropiprant on the antiplatelet activity of co-administered clopidogrel and aspirin. Platelets. 2014;25(7):480-7. doi: 10.3109/09537104.2013.836747. Epub 2013 Nov 8.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

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 niacin (+) laropiprant, Comparator: aspirin and Comparator: clopidogrel in people with Primary Hypercholesterolemia and Mixed Hyperlipidemia, 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Nov 2015. 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. 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 18 Apr 2011). 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?

Cutaneous Bleeding Time (BT) (time frame: Day 8). 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 NCT01012219, which also lists 1 linked publication.

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 2 Nov 2015.