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

Phase 1

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

• Registration Number: EUCTR2008-005002-40-ES
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-17
• Study Completion: 2010-09-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

ATP II High Risk patients >=18 and <80 years of age with primary hypercholesterolemia, either statin/ezetimibe naïve or on an acceptable stable dose, and willing to maintain a cholesterol-lowering diet for the duration of the study. Baseline LDL-C must be between ? 100 mg/dL (2.59 mmol/L) and ? 160 mg/dL (4.14 mmol/L), TG ? 350 mg/dL (3.96 mmol/L), ALT/AST ? 2.0 X ULN, and CK ? 3.0 X ULN.
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified