To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia - Full Text View

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

Purpose

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

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Comparator: ezetimibe/simvastatin + niacin (ER) Drug: Comparator: Placebo to ezetimibe/simvastatin Drug: Comparator: niacin (ER) tablet Drug: Comparator: ezetimibe (+) simvastatin Drug: Comparator: Placebo to Niacin (ER) Drug: Comparator: ezetimibe/simvastatin and niacin (ER) Drug: Comparator: ezetimibe and simvastatin Drug: Comparator: Placebo to niacin (ER)	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Simvastatin Niacinamide Ezetimibe Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Triglycerides (TG) [ Time Frame: baseline and 24 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]

Enrollment:	1220
Study Start Date:	December 2005
Study Completion Date:	February 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part 1 - Arm 1: Active Comparator ezetimibe/simvastatin combination tablet + niacin (ER)	Drug: Comparator: ezetimibe/simvastatin + niacin (ER) ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
Part 1 -Arm 2: Active Comparator ezetimibe/simvastatin	Drug: Comparator: ezetimibe (+) simvastatin ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks. Drug: Comparator: Placebo to Niacin (ER) Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
Part 1 - Arm 3: Active Comparator Niacin (ER)	Drug: Comparator: Placebo to ezetimibe/simvastatin ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks. Drug: Comparator: niacin (ER) tablet niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
Part 2 - Arm 1: Active Comparator ezetimibe/simvastatin combination tablet + niacin (ER)	Drug: Comparator: ezetimibe/simvastatin and niacin (ER) ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
Part 2 - Arm 2: Placebo Comparator ezetimibe/simvastatin combination tablet + niacin (Pbo)	Drug: Comparator: ezetimibe and simvastatin ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks Drug: Comparator: Placebo to niacin (ER) Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 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 less than or equal to 500 mg/dL
Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

Pregnant or 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 ro niacin, any component or niacin extended release or aspirin
Patient for whom discontinuation of existing lipid-lowering therapy treatment 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:

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
Study First Received:	January 3, 2006
Results First Received:	February 13, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00271817 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Niacinamide
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Ezetimibe
Nicotinic Acids
Therapeutic Uses
Vitamins
Micronutrients
Hypercholesterolemia
Dyslipidemias
Metabolic Diseases

Hyperlipidemias
Vitamin B Complex
Simvastatin
Antilipemic Agents
Growth Substances
Enzyme Inhibitors
Cardiovascular Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Niacin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010