"Estudio aleatorizado, doble ciego, con control activo, multicéntrico en pacientes con hipercolesterolemia primaria y alto riesgo cardiovascular y no controlados adecuadamente con Atorvastatina 20 mg: una comparación entre el cambio a un comprimido combinado de Ezetimiba/Simvastatina (10mg/40mg) frente a la duplicación de la dosis basal de Atorvastatina a 40 mg" A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk and not Adequately Controlled with Atorvastatin 20 mg: A Comparison of Switching to a Combination TabletEzetimibe/Simvastatin (10mg/40mg) versus Doubling the Baseline Dose to Atorvastatin 40 mg

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005002-40-ES

Enrollment

240

Registered

2008-09-17

Start date

2008-11-18

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

hipercolesterolemia primaria primary hypercholesterolemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia

Interventions

Trade Name: VYTORIN 10 mg/40 mg comprimidos Pharmaceutical Form: Tablet INN or Proposed INN: EZETIMIBA Other descriptive name: EZETIMIBE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ATP II High Risk patients >=18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient 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
Primary end point(s): Percent change from baseline in LDL-C at endpoint.; Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with atorvastatin 20 mg and with LDL-Cholesterol blood level (LDL-C) ? 100 mg/dl (2.59 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/40mg) compared to atorvastatin 40mg. 2. to evaluate the safety of ezetimibe/simvastatin (10mg/40mg) versus atorvastatin 40 mg. ; Secondary Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with atorvastatin 20 mg and with LDL-Cholesterol blood level (LDL-C) ? 100 mg/dl (2.59 mmol/L) and ? 160 mg/dl (4.14 mmol/L) at baseline: 1. to determine the percentage of patients reaching LDL-C goal of < 70 mg/dL (1.81 mmol/L), < 77 mg/dL (2.0 mmol/L), < 100 mg/dL (2.59 mmol/L) with ezetimibe/simvastatin (10mg/40mg) compared to atorvastatin 40mg following 6 weeks of treatment. 2. to determine the effect of ezetimibe/simvastatin (10mg/40mg) compared to atorvastatin 40 mg on total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, non-HDL-C/HDL-C ratio, Apo B/Apo A-I ratio, Apo B, Apo A-I and hs-C reactive protein (hs-CRP).	—

Measure

Time frame

Primary end point(s): Percent change from baseline in LDL-C at endpoint.; Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with atorvastatin 20 mg and with LDL-Cholesterol blood level (LDL-C) ? 100 mg/dl (2.59 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/40mg) compared to atorvastatin 40mg. 2. to evaluate the safety of ezetimibe/simvastatin (10mg/40mg) versus atorvastatin 40 mg. ; Secondary Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with atorvastatin 20 mg and with LDL-Cholesterol blood level (LDL-C) ? 100 mg/dl (2.59 mmol/L) and ? 160 mg/dl (4.14 mmol/L) at baseline: 1. to determine the percentage of patients reaching LDL-C goal of < 70 mg/dL (1.81 mmol/L), < 77 mg/dL (2.0 mmol/L), < 100 mg/dL (2.59 mmol/L) with ezetimibe/simvastatin (10mg/40mg) compared to atorvastatin 40mg following 6 weeks of treatment. 2. to determine the effect of ezetimibe/simvastatin (10mg/40mg) compared to atorvastatin 40 mg on total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, non-HDL-C/HDL-C ratio, Apo B/Apo A-I ratio, Apo B, Apo A-I and hs-C reactive protein (hs-CRP).

—

Countries

Estonia, Hungary, Latvia, Portugal, Spain

Outcome results

None listed

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