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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)

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ClinicalTrials.gov Identifier: NCT00276458
Recruitment Status : Completed
First Posted : January 13, 2006
Results First Posted : July 8, 2009
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 10, 2006
First Posted Date  ICMJE January 13, 2006
Results First Submitted Date  ICMJE December 18, 2008
Results First Posted Date  ICMJE July 8, 2009
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE February 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 [ Time Frame: 6 weeks ]
[(6 week value - baseline value)/baseline value]*100%.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
Change in LDL-C
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
  • Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6 [ Time Frame: 6 weeks ]
    [(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 ]
    [(6 week value - baseline value)/baseline value]*100%.
  • Percent Change From Baseline in Total-Cholesterol at Week 6 [ Time Frame: 6 Weeks ]
    ([6 week value - baseline value)/baseline value]*100%.
  • Percent Change From Baseline in Triglycerides (TG) at Week 6 [ Time Frame: 6 weeks ]
    [(6 week value - baseline value)/baseline value]*100%.
  • Percent Change From Baseline in Apolipoprotein B at Week 6 [ Time Frame: 6 Weeks ]
    [(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 ]
    [(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 ]
    [(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 ]
    [(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 ]
    [(6 week value - baseline value)/baseline value]*100%.
  • Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6 [ Time Frame: 6 Weeks ]
    [(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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
Change in other lipid variables
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1
    Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
    Interventions:
    • Drug: Comparator: atorvastatin
    • Drug: Comparator: Placebo
  • Experimental: 2
    Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
    Interventions:
    • Drug: Comparator: ezetimibe
    • Drug: Comparator: Placebo.
Publications * Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2009)
196
Original Enrollment  ICMJE
 (submitted: January 11, 2006)
328
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Austria,   Canada,   Costa Rica,   United States
 
Administrative Information
NCT Number  ICMJE NCT00276458
Other Study ID Numbers  ICMJE 0653-079
2005_104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP