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

Primary Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012219
• Other study ID #: 0524A-114
• Secondary ID: 2009_689
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2009
• Last updated: October 30, 2015
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)

• Participant is a non-smoker

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipidemia
• Primary Hypercholesterolemia

Intervention

Drug:
• niacin (+) laropiprant
open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
• Comparator: aspirin
81 mg oral tablet once daily for 7 days
• Comparator: clopidogrel
75 mg oral tablet once daily for 7 days
• Comparator: laropiprant
40 mg oral tablet once daily for 7 days
• Comparator: placebo
placebo oral tablet once daily for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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: 10.3109/09537104.2013.83 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No