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Ezetimibe/Simvastatin (MK0653A) vs Rosuvastatin vs Doubling Statin Dose in Patients With Cardiovascular Disease and Diabetes Mellitus
This study is currently recruiting participants.
Verified by Merck, January 2010
First Received: March 12, 2009   Last Updated: January 27, 2010   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00862251
  Purpose

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) vs rosuvastatin (10 mg) vs 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.


Condition Intervention Phase
Cardiovascular Disorder
Diabetes Mellitus
Drug: ezetimibe (+) simvastatin
Drug: Comparator: simvastatin 40 mg or atorvastatin 20 mg
Drug: Comparator: rosuvastatin
Drug: Comparator: atorvastatin 10 mg or simvastatin 20 mg
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official 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 vs Switching to Rosuvastatin or Doubling the Statin Dose

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ezetimibe/simvastatin
Drug: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
Drug: Comparator: 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.
2: Active Comparator
Doubling statin dose.
Drug: Comparator: simvastatin 40 mg or atorvastatin 20 mg
simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Drug: Comparator: 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.
3: Active Comparator
rosuvastatin 10 mg tablets
Drug: Comparator: rosuvastatin
rosuvastatin 10 mg tablets, taken once daily for six weeks.
Drug: Comparator: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 HIV positive
  • Patient is currently taking medications that inhibit 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862251

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 33 Study Locations
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2009_559, MK0653A-133
Study First Received: March 12, 2009
Last Updated: January 27, 2010
ClinicalTrials.gov Identifier: NCT00862251     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
cardiovascular disorder

Additional relevant MeSH terms:
Antimetabolites
Disease
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pathologic Processes
Rosuvastatin
Therapeutic Uses
Cardiovascular Diseases
Glucose Metabolism Disorders
Atorvastatin

ClinicalTrials.gov processed this record on February 04, 2010