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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: March 7, 2017
Last verified: March 2017
January 10, 2006
March 7, 2017
February 2006
January 2008   (Final data collection date for primary outcome measure)
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%.
Change in LDL-C
Complete list of historical versions of study NCT00276458 on ClinicalTrials.gov Archive Site
  • 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 ]
Change in other lipid variables
Not Provided
Not Provided
 
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Hypercholesterolemia
  • 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.
  • 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.
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.
 
Completed
196
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Canada,   Costa Rica,   United States
 
NCT00276458
0653-079
2005_104
Not Provided
Not Provided
Yes

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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

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