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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007689-52-LT

Enrollment

800

Registered

2009-03-24

Start date

2009-05-27

Completion date

Unknown

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipids not at goal in diabetic patients with cardiovascular disease MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia

Interventions

Trade Name: Zocor Product Name: Zocor Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with diabetes mellitus (Type 1 or 2) with cardiovascular disease, >=18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: In patients with cardiovascular disease (CVD) and diabetes mellitus treated with simvastatin 20 mg or atorvastatin 10 mg with LDL-Cholesterol blood level (LDL-C) =70 mg/dl (1.81 mmol/L) and =160 mg/dl (4.14 mmol/L) at baseline: 1. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to doubling the baseline statin dose. 2. to evaluate the safety of ezetimibe/simvastatin (10mg/20mg) versus statin at double the baseline dose and rosuvastatin 10 mg. ;Secondary Objective: In patients with cardiovascular disease and diabetes mellitus treated with simvastatin 20 mg or atorvastatin 10 mg and with LDL-Cholesterol blood level (LDL-C) =70 mg/dl (1.81 mmol/L) and =160 mg/dl (4.14 mmol/L) at baseline: 1. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to simvastatin 40 mg in the subpopulation of patients treated with simvastatin 20 mg at baseline. 2. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to atorvastatin 20 mg in the subpopulation of patients treated with atorvastatin 10 mg at baseline. 3. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg. 4. to determine the percentage of patients reaching LDL-C goal of <70 mg/dL (1.81 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to statin at double the baseline dose. ;Primary end point(s): Percent change from baseline in LDL-C at endpoint.	—

Measure

Time frame

Main Objective: In patients with cardiovascular disease (CVD) and diabetes mellitus treated with simvastatin 20 mg or atorvastatin 10 mg with LDL-Cholesterol blood level (LDL-C) =70 mg/dl (1.81 mmol/L) and =160 mg/dl (4.14 mmol/L) at baseline: 1. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to doubling the baseline statin dose. 2. to evaluate the safety of ezetimibe/simvastatin (10mg/20mg) versus statin at double the baseline dose and rosuvastatin 10 mg. ;Secondary Objective: In patients with cardiovascular disease and diabetes mellitus treated with simvastatin 20 mg or atorvastatin 10 mg and with LDL-Cholesterol blood level (LDL-C) =70 mg/dl (1.81 mmol/L) and =160 mg/dl (4.14 mmol/L) at baseline: 1. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to simvastatin 40 mg in the subpopulation of patients treated with simvastatin 20 mg at baseline. 2. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to atorvastatin 20 mg in the subpopulation of patients treated with atorvastatin 10 mg at baseline. 3. to assess the incremental LDL-C percentage reduction by switching to ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg. 4. to determine the percentage of patients reaching LDL-C goal of <70 mg/dL (1.81 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to statin at double the baseline dose. ;Primary end point(s): Percent change from baseline in LDL-C at endpoint.

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Countries

Austria, Bulgaria, Estonia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Portugal

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026