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To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00276484
First received: January 11, 2006
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.


Condition Intervention Phase
Hypercholesterolemia
Drug: atorvastatin
Drug: ezetimibe
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, Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%


Secondary Outcome Measures:
  • Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%

  • Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%

  • Percent Change From Baseline to Week 6 in Total-Cholesterol [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%

  • Percent Change From Baseline to Week 6 in Triglycerides (TG) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%

  • Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%

  • Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%

  • Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

  • Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

  • Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

  • Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

  • Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%

  • Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 579
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Atorvastatin 80 mg
Drug: atorvastatin
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
Experimental: 2
Atorvastatin 40 mg + ezetimibe 10 mg
Drug: atorvastatin
Atorvastatin 40 mg by mouth, once a day for 6 weeks
Drug: ezetimibe
Ezetimibe 10 mg tablets by mouth, once a day for 6 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 >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion Criteria:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe 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: NCT00276484

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: NCT00276484     History of Changes
Other Study ID Numbers: 0653-090, 2005_105
Study First Received: January 11, 2006
Results First Received: February 6, 2009
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
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 27, 2014