NCT00862251

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 808 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardiovascular Disorder
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ezetimibe (+) simvastatin	ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
DRUG	simvastatin 40 mg or atorvastatin 20 mg	simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
DRUG	Rosuvastatin	rosuvastatin 10 mg tablets, taken once daily for six weeks.
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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-03-16
• Last updated: 2024-05-16
• Results posted: 2012-03-16