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

Condition(s) targeted: Primary Hypercholesterolemia; Dyslipidemia

Intervention: ER niacin/laropiprant/simvastatin (Drug); ER niacin/laropiprant/simvastatin (Drug); ER niacin/laropiprant (Drug); Simvastatin (Drug); Placebo to match simvastatin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

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.

Official title: A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in low-density lipoprotein cholesterol (LDL-C) blood levels.

Secondary outcome:

Change from baseline in high-density lipoprotein cholesterol (HDL-C) blood levels.

Difference between percent change from baseline for LDL-C with ER/LRPT/SIM versus ERN/LRPT + SIM.

Difference between percent change from baseline for HDL-C with ER/LRPT/SIM versus ERN/LRPT + SIM.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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, 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.

- Patient consumes >1 quart of grapefruit juice/day.

Starting date: February 2011
Last updated: October 27, 2014