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Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Hypercholesterolemia; Mixed Dyslipidemia

Intervention: extended release (ER) niacin/laropiprant/simvastatin (Drug); ER niacin/laropiprant (Drug); simvastatin (Drug); Placebo to simvastatin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of 1 g/10 mg Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablets in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), 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

Eligibility

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.

- Participant is high risk coronary heart disease (CHD) and has LDL-C ≤190 mg/dL (≤4. 91

mmol/L)

- Participant is not high risk CHD and has LDL-C ≤240 mg/dL (≤6. 21 mmol/L).

Exclusion criteria:

- Participant is pregnant or breast-feeding, or expecting to conceive or donate eggs or

sperm during the study.

- Participant has a history of malignancy within ≤5 years, except for adequately

treated basal cell or squamous cell skin cancer or in situ cervical cancer.

- Participant consumes more than 3 alcoholic drinks per day (14 per week).

- Participant is a high risk CHD patient on lipid modifying therapy (LMT).

- Participant on any LMT with equivalent or greater LDL-C-lowering efficacy than

simvastatin 40 mg.

- 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 has 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,

3-hydroxy-3-methylglutaryl-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, potent

inhibitors of Cytochrome P450 3A4 (CYP3A4), cyclosporine, danazol, or fusidic acid.

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

- Participant requires warfarin treatment and has not been on a stable dose with a

stable International Normalized Ratio (INR) for at least 6 weeks prior to Visit 1.

Locations and Contacts

Call for Information, Birmingham, Alabama 35209, United States

Call for Information, Chandler, Arizona 85224, United States

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Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico City, D.f. 1090, Mexico

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Additional Information

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

Page last updated: August 23, 2015

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