To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With High Cholesterol - Full Text View

Purpose

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe (+) simvastatin Drug: niacin (ER) tablet Drug: ezetimibe/simvastatin + niacin (ER) Drug: Placebo (unspecified)	Phase III

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

Drug Information available for:

Simvastatin Ezetimibe Cholest-5-en-3-ol (3beta)- Niacin Niacin hydrochloride Vytorin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

Further study details as provided by Merck:

Primary Outcome Measures:

Change in non-HDL-C [ Time Frame: 1 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in other lipid variables [ Time Frame: 1 Years ] [ Designated as safety issue: No ]

Enrollment:	990
Study Start Date:	November 2005
Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Active Comparator ezetimibe/simvastatin combination tablet + niacin (ER)	Drug: ezetimibe/simvastatin + niacin (ER) ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~16 weeks. Drug: Placebo (unspecified) ezetimibe/simvastatin (Pbo) tablet niacin (ER) (Pbo) tablet, titrating to 2g, po qd. Treatment time will be ~16 weeks.
2: Active Comparator niacin (ER)	Drug: niacin (ER) tablet niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~16 weeks. Drug: Placebo (unspecified) ezetimibe/simvastatin (Pbo) tablet niacin (ER) (Pbo) tablet, titrating to 2g, po qd. Treatment time will be ~16 weeks.
3: Active Comparator ezetimibe/simvastatin	Drug: ezetimibe (+) simvastatin ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~16 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with LDL-C of 130 through 190 mg/dL and Triglycerides </= 500 mg/dL
Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

Pregnant of lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
Patient with sensitivity or intolerance to niacin, any component of niacin extended release of aspirin
Patient for whom discontinuation of existing lipid-lowering therapy poses an unacceptable risk

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271817

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Publications indexed to this study:

Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_091, MK0653A-091
First Received:	January 3, 2006
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00271817
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Nicotinic Acids

Metabolic Diseases

Hyperlipidemias

Simvastatin

Ezetimibe

Metabolic disorder

Niacin

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Vasodilator Agents

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Antilipemic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Anticholesteremic Agents

Cardiovascular Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

Therapeutic Uses

Vitamins

Micronutrients

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00271817