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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)

This study has been completed.
Sponsor:
Collaborator:
Merck Shering-Plough JV Study
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00535405
First received: September 25, 2007
Last updated: October 31, 2014
Last verified: October 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Merck Shering-Plough JV Study
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535405     History of Changes
Other Study ID Numbers: 0653A-128, 2007_588
Study First Received: September 25, 2007
Results First Received: April 26, 2010
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
High Cholesterol

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Hypercholesterolemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Anticholesteremic Agents
Atorvastatin
Ezetimibe
Simvastatin
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014