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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01294683
First received: February 10, 2011
Last updated: May 29, 2012
Last verified: May 2012
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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:
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01294683 History of Changes |
| Other Study ID Numbers: | MK-0524B-118, 2010-023939-42 |
| Study First Received: | February 10, 2011 |
| Last Updated: | May 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Low-density lipoprotein LDL High-density lipoprotein HDL Niacin |
Lipid modifying therapy Cholesterol High cholesterol Triglycerides Mixed Dyslipidemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Niacin Simvastatin Nicotinic Acids Niacinamide Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013