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

ClinicalTrials.gov Identifier:

NCT01294683

First received: February 10, 2011

Last updated: May 29, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 10, 2011
Last Updated Date	May 29, 2012
Start Date ^ICMJE	February 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2011)	Change from baseline in low-density lipoprotein cholesterol (LDL-C) blood levels. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01294683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 10, 2011)	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 ]
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	A Study to Evaluate Efficacy and Safety of Extended-Release Niacin (+) Laropiprant (+) Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
Official Title ^ICMJE	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
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 Primary Purpose: Treatment
Condition ^ICMJE	Primary Hypercholesterolemia Dyslipidemia
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: ERN/LRPT/SIM - ERN/LRPT+SIM Interventions: Drug: ER niacin/laropiprant/simvastatin Drug: ER niacin/laropiprant/simvastatin Drug: ER niacin/laropiprant Drug: Simvastatin Drug: Placebo to match simvastatin Active Comparator: ERN/LRPT+SIM - ERN/LRPT/SIM Interventions: Drug: ER niacin/laropiprant/simvastatin Drug: ER niacin/laropiprant Drug: Simvastatin Drug: Placebo to match 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	977
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. 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.
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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01294683
Other Study ID Numbers ^ICMJE	MK-0524B-118, 2010-023939-42
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	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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