A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)

NCT ID: NCT01294683

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 977 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-04
• Study Completion Date: 2012-01-17

Brief Summary

This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).

Conditions

Primary Hypercholesterolemia; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg

After a 2-week placebo run-in, participants received extended release (ER) niacin/laropiprant (N/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM)

Intervention Type: DRUG

Extended Release (ER) niacin/laropiprant (N/LRPT)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g

After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM)

Intervention Type: DRUG

Extended Release (ER) niacin/laropiprant (N/LRPT)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Simvastatin

Intervention Type: DRUG

Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM)

Intervention Type: DRUG

Extended Release (ER) niacin/laropiprant (N/LRPT)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Zocor; MK-0524B; MK-0524A

Eligibility Criteria

Inclusion Criteria

• Participant has a history of primary hypercholesterolemia or mixed dyslipidemia and meets LDL-C and triglyceride criteria.
• Visit 2:
• Participant is high risk coronary heart disease (CHD) or CHD risk-equivalent.

Exclusion Criteria

• Participant is pregnant or breast-feeding, or expecting to conceive during the study.
• Participant has a history of malignancy.
• Participant consumes more than 3 alcoholic drinks per day (14 per week).
• Participant is high risk CHD patient on statin therapy or any patient on statin therapy equivalent to 80 mg simvastatin.
• Participant with Type 1 or Type 2 diabetes mellitus that is poorly controlled, or on statin therapy.
• Participant currently engages in vigorous exercise or is on an aggressive diet regimen.
• Participant uncontrolled endocrine or metabolic disease, uncontrolled gout, kidney or hepatic disease, heart failure, recent peptic ulcer disease, hypersensitivity or allergic reaction to niacin or simvastatin, recent heart attack, stroke or heart surgery.
• Participant is human immunodeficiency virus (HIV) positive.
• Participant has taken niacin >50 mg/day, bile-acid sequestrants, hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase inhibitors, ezetimibe, Cholestin™ [red yeast rice] and other red yeast products within 6 weeks, or fibrates within 8 weeks of randomization visit (Visit 3).

• Note: Fish oils, phytosterol margarines and other non-prescribed therapies are allowed provided participant has been on a stable dose for 6 weeks prior to Visit 2 and agrees to remain on this dose for the duration of the study.
• Participant is currently receiving cyclical hormonal contraceptives or intermittent use of hormone replacement therapies (HRTs) (e.g., estradiol, medroxyprogesterone, progesterone).

• Note: Participants who have been on a stable dose of non-cyclical HRT or hormonal contraceptive for greater than 6 weeks prior to Visit 1 are eligible if they agree to remain on the same regimen for the duration of the study.
• Participant is taking prohibited medications such as systemic corticosteroids, itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, HIV protease inhibitors, verapamil, amiodarone, cyclosporine, danazol, diltiazem or fusidic acid.
• Participant consumes >1 quart of grapefruit juice/day.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis Link

View Document

Other Identifiers

2010-023939-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0524B-118

Identifier Type: -

Identifier Source: org_study_id