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Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862251
First Posted: March 16, 2009
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
March 12, 2009
March 16, 2009
February 23, 2012
March 16, 2012
April 14, 2017
April 2009
March 2011   (Final data collection date for primary outcome measure)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). [ Time Frame: Baseline and Week 6 ]
Percent reduction of LDL-C after switching to treatment with ezetimibe/simvastatin vs doubling the dose of statin (simvastatin or atorvastatin). [ Time Frame: Six weeks ]
Complete list of historical versions of study NCT00862251 on ClinicalTrials.gov Archive Site
  • In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin [ Time Frame: Baseline and Week 6 ]
  • In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin [ Time Frame: Baseline and Week 6 ]
  • Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ]
  • In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ]
  • In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ]
  • Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in Triglycerides [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in LDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in TC/HDL-C Ratio [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in Non-HDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in Apo B/Apo A-I Ratio [ Time Frame: Baseline and Week 6 ]
  • Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline and Week 6 ]
In patients treated with simvastatin at baseline, percent reduction of LDL-C after switching to treatment with ezetimibe/simvastatin vs doubling the dose of simvastatin. [ Time Frame: Six weeks ]
Not Provided
Not Provided
 
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Cardiovascular Disorder
  • Diabetes Mellitus
  • Drug: ezetimibe (+) simvastatin
    ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
    Other Name: Vytorin
  • Drug: simvastatin 40 mg or atorvastatin 20 mg
    simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
    Other Name: Lipitor, Zocor
  • Drug: Rosuvastatin
    rosuvastatin 10 mg tablets, taken once daily for six weeks.
    Other Name: Crestor
  • Drug: atorvastatin 10 mg or simvastatin 20 mg
    All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
    Other Name: Lipitor, Zocor
  • Experimental: Ezetimibe/simvastatin
    Interventions:
    • Drug: ezetimibe (+) simvastatin
    • Drug: atorvastatin 10 mg or simvastatin 20 mg
  • Active Comparator: Doubling statin dose
    Interventions:
    • Drug: simvastatin 40 mg or atorvastatin 20 mg
    • Drug: atorvastatin 10 mg or simvastatin 20 mg
  • Active Comparator: Rosuvastatin
    Interventions:
    • Drug: Rosuvastatin
    • Drug: atorvastatin 10 mg or simvastatin 20 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
808
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
  • Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
  • Patient is willing to remain abstinent or use birth control for the duration of the study
  • Patient has Diabetes Mellitus with cardiovascular disease

Exclusion Criteria:

  • Patient has sensitivity to certain common statin drugs
  • Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
  • Patient consumes more than 2 alcoholic drinks per day
  • Patient is pregnant or breast-feeding
  • Patient has been treated with other investigational drugs within 30 days of first visit
  • Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin
  • Patient has congestive heart failure
  • Patient has uncontrolled high blood pressure
  • Patient has kidney disease
  • Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins
  • Patient has diabetes mellitus that is not well controlled
  • Patient is human immunodeficiency virus (HIV) positive
  • Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)
  • Patient is currently taking therapies that would increase the risk of muscle weakness
  • Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1
  • Patient is currently taking psyllium or other fiber-based laxatives
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,   Bulgaria,   Chile,   Costa Rica,   Croatia,   Egypt,   Estonia,   Germany,   Greece,   Hungary,   Italy,   Latvia,   Lithuania,   Peru,   Portugal,   United States
 
NCT00862251
0653A-133
2009_559 ( Other Identifier: Merck Study Number )
No
Not Provided
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

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