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

ClinicalTrials.gov Identifier:

NCT01335997

First received: April 13, 2011

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 13, 2011
Last Updated Date	April 26, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 14, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01335997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 14, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
Official Title ^ICMJE	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
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Primary Hypercholesterolemia Mixed Dyslipidemia
Intervention ^ICMJE	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
Study Arm (s)	Experimental: ERN/LRPT/SIM - ERN/LRPT+SIM Interventions: Drug: extended release (ER) niacin/laropiprant/simvastatin Drug: ER niacin/laropiprant Drug: simvastatin Drug: Placebo to simvastatin Active Comparator: ERN/LRPT+SIM - ERN/LRPT/SIM Interventions: Drug: extended release (ER) niacin/laropiprant/simvastatin Drug: ER niacin/laropiprant Drug: simvastatin Drug: Placebo to simvastatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	1139
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Mexico

Administrative Information
NCT Number ^ICMJE	NCT01335997
Other Study ID Numbers ^ICMJE	MK-0524B-143, 2011-001007-12
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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