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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01294683
First received: February 10, 2011
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Primary Hypercholesterolemia
Dyslipidemia
Drug: ER niacin/laropiprant/simvastatin
Drug: ER niacin/laropiprant
Drug: Simvastatin
Drug: Placebo to match simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in low-density lipoprotein cholesterol (LDL-C) blood levels. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in high-density lipoprotein cholesterol (HDL-C) blood levels. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Difference between percent change from baseline for LDL-C with ER/LRPT/SIM versus ERN/LRPT + SIM. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Difference between percent change from baseline for HDL-C with ER/LRPT/SIM versus ERN/LRPT + SIM. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 977
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ERN/LRPT/SIM - ERN/LRPT+SIM Drug: ER niacin/laropiprant/simvastatin
One tablet containing 1 g extended release niacin, 20 mg laropiprant, and 40 mg simvastatin, orally, once daily.
Other Name: MK-0524B
Drug: ER niacin/laropiprant/simvastatin
Two tablets containing 1 g extended release niacin, 20 mg laropiprant, and 20 mg simvastatin, orally, once daily.
Drug: ER niacin/laropiprant
One or two tablets containing 1 g extended release niacin and 20 mg laropiprant, orally, once daily
Other Name: MK-0524A, Tredaptive™
Drug: Simvastatin
One tablet, containing 40 mg simvastatin, orally, once daily
Drug: Placebo to match simvastatin
One tablet, orally, once daily.
Active Comparator: ERN/LRPT+SIM - ERN/LRPT/SIM Drug: ER niacin/laropiprant/simvastatin
Two tablets containing 1 g extended release niacin, 20 mg laropiprant, and 20 mg simvastatin, orally, once daily.
Drug: ER niacin/laropiprant
One or two tablets containing 1 g extended release niacin and 20 mg laropiprant, orally, once daily
Other Name: MK-0524A, Tredaptive™
Drug: Simvastatin
One tablet, containing 40 mg simvastatin, orally, once daily
Drug: Placebo to match simvastatin
One tablet, orally, once daily.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01294683     History of Changes
Other Study ID Numbers: 0524B-118, 2010-023939-42
Study First Received: February 10, 2011
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Low-density lipoprotein
LDL
High-density lipoprotein
HDL
Niacin
Lipid modifying therapy
Cholesterol
High cholesterol
Triglycerides
Mixed Dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Simvastatin
Anticholesteremic Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Growth Substances
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014