A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10mg/20mg) compared to Rosuvastatin 10mg in patients with primary hypercholesterolemia and high cardiovascular risk and not adequately controlled with a prior statin treatment. (IN-CROSS).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005513-35-FR

Enrollment

1200

Registered

2007-01-11

Start date

2007-02-05

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Adjunctive therapy to diet for the reduction of elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia. MedDRA version: 8.1 Level: HLT Classification code 10014476 Term: Elevated cholesterol

Interventions

Trade Name: Inegy Product Name: Inegy Product Code: MK-0653A Pharmaceutical Form: Tablet INN or Proposed INN: ezetimibe / simvastatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: LDL-C level = 100 mg/dL (2.50 mmol/L) and = 190 mg/dl (4.9 mmol/L) (sample collected at visit 1) 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 liver or kidney disease Female pregnant or lactating Patient with Heart Failure NYHA Class III and IV Myocradial infarction, coronary arthery by-pass surgery or angioplasthy within 3 months before V1 HBA1c uncontrolled > 8.5 %

Design outcomes

Primary

Measure	Time frame
Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with a statin and with elevated LDL-Cholesterol at baseline to assess the additional LDL-C percentage reduction by switching to ezetimibe/simvastatin compared to rosuvastatin.; Secondary Objective: 1 to determine the percentage of patients reaching LDL-C <100 mg/dL (2.5 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg 2 to determine the percentage of patients reaching LDL-C < 70 mg/dL (1.8 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg ;Primary end point(s): LDL cholesterol lowering	—

Measure

Time frame

Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with a statin and with elevated LDL-Cholesterol at baseline to assess the additional LDL-C percentage reduction by switching to ezetimibe/simvastatin compared to rosuvastatin.; Secondary Objective: 1 to determine the percentage of patients reaching LDL-C <100 mg/dL (2.5 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg 2 to determine the percentage of patients reaching LDL-C < 70 mg/dL (1.8 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg ;Primary end point(s): LDL cholesterol lowering

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Countries

Belgium, Czech Republic, Estonia, France, Italy, Latvia, Lithuania, Netherlands, Portugal

Outcome results

None listed

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