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

NCT01012219 | Completed Phase 1 Results

• 2 other identifiers: 0524A-1142009_689
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.

Conditions

Primary Hypercholesterolemia; Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 8

Study Arms (3)

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).

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).

Drug: Comparator: aspirin; Drug: Comparator: clopidogrel; Drug: Comparator: laropiprant; Drug: Comparator: placebo

Period 3

EXPERIMENTAL

Drug: niacin (+) laropiprant

Interventions

niacin (+) laropiprant DRUG

open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets

Also known as: Tredaptive

Period 3

Comparator: aspirin DRUG

81 mg oral tablet once daily for 7 days

Period 1; Period 2

Comparator: clopidogrel DRUG

75 mg oral tablet once daily for 7 days

Period 1; Period 2

Comparator: laropiprant DRUG

40 mg oral tablet once daily for 7 days

Period 1; Period 2

Comparator: placebo DRUG

placebo oral tablet once daily for 7 days

Period 1; Period 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 24206527 RESULT

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Niacin; MK-0524

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 2, 2015
• Results First Posted: April 18, 2011

Record last verified: 2015-10