A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled with Simvastatin 20 mg or Atorvastatin 10 mg: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin (10mg/20mg) Versus Switching to Rosuvastatin 10mg or Doubling the Statin Dose

• Conditions: ipids not at goal in diabetic patients with cardiovascular disease

• Registration Number: EUCTR2008-007689-52-EE
• Lead Sponsor: Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Patients with diabetes mellitus (Type 1 or 2) with cardiovascular disease, >=18 and <80 years of age with inadequately controlled lipids, either statin/ezetimibe naïve or on an acceptable stable dose, and willing to maintain a cholesterol-lowering and glucose-lowering diet for the duration of the study. Baseline LDL-C must be between = 70 mg/dL (1.81 mmol/L) and = 160 mg/dL (4.14 mmol/L), TG = 400 mg/dL (4.52 mmol/L), ALT/AST = 2.0 X ULN, and CK = 3.0 X ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient is Asian, is hypersensitive/intolerant to any component of the study medication, has CHF NYHA Class III or IV, is an uncontrolled hypertensive or diabetic, or is actively trying to lose weight. Prohibited medications include CYP3A4 inhibitors, lipid-lowering agents, systemic corticosteroids, anti-obesity medications, warfarin, or medications that could increase the risk of myopathy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified