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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." - N/A

"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." - N/A

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006497-17-GR
Enrollment
1120
Registered
2007-07-12
Start date
2008-01-22
Completion date
Unknown
Last updated
2019-12-10

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/Simvastatin Concentration unit: mg mill

Sponsors

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.

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