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To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00276458
First received: January 10, 2006
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.


Condition Intervention Phase
Hypercholesterolemia
Drug: Comparator: atorvastatin
Drug: Comparator: Placebo
Drug: Comparator: ezetimibe
Drug: Comparator: Placebo.
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 Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

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-Cholesterol (LDL-C) at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    [(6 week value - baseline value)/baseline value]*100%.


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

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

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

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

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

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

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

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

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

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

  • Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: February 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
Drug: Comparator: atorvastatin
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
Drug: Comparator: Placebo
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
Experimental: 2
Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
Drug: Comparator: ezetimibe
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
Drug: Comparator: Placebo.
Atorvastatin 40mg Pbo tablets po qd (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 >100 mg/dL & on a stable dose of atorvastatin 20 mg

Exclusion Criteria:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin
  • Patient with diabetes or coronary heart disease
  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: NCT00276458

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00276458     History of Changes
Other Study ID Numbers: 0653-079, 2005_104
Study First Received: January 10, 2006
Results First Received: December 18, 2008
Last Updated: October 31, 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