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A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients with Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients with Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006497-17-DE
Enrollment
1120
Registered
2007-03-02
Start date
2007-05-21
Completion date
Unknown
Last updated
2013-05-06

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

Conditions

Hypercholesterolemia MedDRA version: 8.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia

Interventions

Trade Name: Inegy Product Name: Inegy Pharmaceutical Form: Tablet INN or Proposed INN: ezetimibe Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed

Sponsors

MSP Singapore Co., LLC c/o Merck & Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient has a diagnosis of metabolic syndrome and hyperclosterolemia. 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

Exclusion criteria: Patients with screening lab values/findings outside required ranges. Patients previously participating in a study with torcetrapib within 1 year of visit 1.

Design outcomes

Primary

MeasureTime frame
Main Objective: In high risk patients for CHD with metabolic syndrome and hypercholesterolemia, to evaluate the LDL-C lowering efficacy of the ezetimibe/simvastatin combination tablet compared to atorvastatin. ;Secondary Objective: Evaluate the percentage of patients achieving a serum LDL-C <70 mg/dL (1.81 mmol/L) after 6 weeks of treatment. ;Primary end point(s): LDL cholesterol lowering—

Countries

Germany, Greece, Hungary, Italy, Netherlands

Outcome results

None listed

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