Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00418834
First received: January 3, 2007
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe and atorvastatin
Drug: atorvastatin
Drug: Placebo (unspecified)
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 Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change From Baseline in LDL-C at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseine and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol (TC) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglycerides (TG) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglycerides (TG) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 1053
Study Start Date: January 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: ezetimibe and atorvastatin
ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
Drug: Placebo (unspecified)
Placebo (unspecified) daily for 12 weeks
Active Comparator: 2 Drug: atorvastatin
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
Drug: Placebo (unspecified)
Placebo (unspecified) 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 is age 65 or older
  • Patient is willing to maintain cholesterol lowering diet
  • Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study
  • Patient is unlikely to be compliant in taking study medication
  • Patient with chronic or unstable medical condition
  • Patient is taking unstable doses of medication
  • Patient drinks more than 2 alcoholic drinks per day
  • Patient has elevations in certain laboratory values (CK, AST, ALT)
  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: NCT00418834

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00418834     History of Changes
Other Study ID Numbers: 0653-112, MK0653-112, 2006_549
Study First Received: January 3, 2007
Results First Received: August 25, 2009
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Disease
Hypercholesterolemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
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 August 28, 2014