A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128) - Full Text View

Purpose

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Atorvastatin 10 mg Drug: Ezetimibe 10 mg/simvastatin 20 mg Drug: Atorvastatin 20 mg Drug: Ezetimibe 10 mg/simvastatin 40 mg Drug: Atorvastatin 40 mg	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin Atorvastatin calcium Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

Enrollment:	1289
Study Start Date:	November 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Atorvastatin 10 mg Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Experimental: 2 Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Ezetimibe 10 mg/simvastatin 20 mg Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
Experimental: 3 Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Atorvastatin 20 mg Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Experimental: 4 Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Ezetimibe 10 mg/simvastatin 40 mg Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
Experimental: 5 Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Atorvastatin 40 mg Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has a cholesterol level of 130 mg/dL or greater
Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

Patient weighs less than 100 lbs
Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535405

Sponsors and Collaborators

Merck

Merck Shering-Plough JV Study

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00535405 History of Changes
Other Study ID Numbers:	2007_588, MK0653A-128
Study First Received:	September 25, 2007
Results First Received:	April 26, 2010
Last Updated:	April 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

High Cholesterol

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

Anticholesteremic Agents
Simvastatin
Atorvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013