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OpenTrials
Completed

NCT Number: NCT00862251

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe (+) simvastatin

Drug

ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.

Other names: Vytorin

simvastatin 40 mg or atorvastatin 20 mg

Drug

simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.

Other names: Lipitor, Zocor

Rosuvastatin

Drug

rosuvastatin 10 mg tablets, taken once daily for six weeks.

Other names: Crestor

atorvastatin 10 mg or simvastatin 20 mg

Drug

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 names: Lipitor, Zocor

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

    Time frame: Week 6

  5. 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

  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

  7. Percent Change From Baseline in Total Cholesterol (TC)

    Time frame: Baseline and Week 6

  8. Percent Change From Baseline in Triglycerides

    Time frame: Baseline and Week 6

  9. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline and Week 6

  10. Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: Baseline and Week 6

  11. Percent Change From Baseline in LDL-C/HDL-C Ratio

    Time frame: Baseline and Week 6

  12. Percent Change From Baseline in TC/HDL-C Ratio

    Time frame: Baseline and Week 6

  13. Percent Change From Baseline in Non-HDL-C/HDL-C Ratio

    Time frame: Baseline and Week 6

  14. Percent Change From Baseline in Apolipoprotein B (Apo B)

    Time frame: Baseline and Week 6

  15. Percent Change From Baseline Apolipoprotein A-I (Apo A-I)

    Time frame: Baseline and Week 6

  16. Percent Change From Baseline in Apo B/Apo A-I Ratio

    Time frame: Baseline and Week 6

  17. Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Baseline and Week 6

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2009
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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