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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01335997
First received: April 13, 2011
Last updated: April 26, 2012
Last verified: April 2012
  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
Mixed Dyslipidemia
Drug: extended release (ER) niacin/laropiprant/simvastatin
Drug: ER niacin/laropiprant
Drug: simvastatin
Drug: Placebo to simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

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: Baseline to end of 8 week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in high density lipoprotein cholesterol (HDL-C) blood levels [ Time Frame: Baseline to end of 8 week treatment period ] [ Designated as safety issue: No ]

Enrollment: 1139
Study Start Date: May 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: extended release (ER) niacin/laropiprant/simvastatin
1 or 2 tablets containing 1 g ER niacin, 20 mg laropiprant and 10 mg simvastatin, orally, once daily
Other Name: MK-0524B
Drug: ER niacin/laropiprant
1 or 2 tablets containing 1g ER niacin and 20 mg laropiprant, orally, once daily
Other Name: MK-0524A, Tredaptive™
Drug: simvastatin
1 or 2 tablets containing 10 mg simvastatin, orally, once daily
Other Name: Zocor®
Drug: Placebo to simvastatin
1 or 2 tablets to match simvastatin, orally, once daily
Active Comparator: ERN/LRPT+SIM - ERN/LRPT/SIM Drug: extended release (ER) niacin/laropiprant/simvastatin
1 or 2 tablets containing 1 g ER niacin, 20 mg laropiprant and 10 mg simvastatin, orally, once daily
Other Name: MK-0524B
Drug: ER niacin/laropiprant
1 or 2 tablets containing 1g ER niacin and 20 mg laropiprant, orally, once daily
Other Name: MK-0524A, Tredaptive™
Drug: simvastatin
1 or 2 tablets containing 10 mg simvastatin, orally, once daily
Other Name: Zocor®
Drug: Placebo to simvastatin
1 or 2 tablets to match simvastatin, 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.
  • 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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335997

  Show 63 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01335997     History of Changes
Other Study ID Numbers: MK-0524B-143, 2011-001007-12
Study First Received: April 13, 2011
Last Updated: April 26, 2012
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

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 October 22, 2014