Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia

NCT01420549 ↗

Phase 3 Completed 129 enrolled Ache Laboratorios Farmaceuticos S.A.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the non-inferiority between two different FDC (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with primary hypercholesterolemia or mixed dyslipidemia.

Timeline

Start: 2013-03
Primary completion: 2014-11
Completion: 2014-11

Publications

Vattimo ACA, Fonseca FAH, Morais DC, Generoso LF, Herrera R, Barbosa CM, de Oliveira Izar MC, Cardoso RA, Zung S. Efficacy and Tolerability of a Fixed-Dose Combination of Rosuvastatin and Ezetimibe Compared with a Fixed-Dose Combination of Simvastatin and Ezetimibe in Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized Trial. Curr Ther Res Clin Exp. 2020 Jul 28;93:100595. doi: 10.1016/j.curtheres.2020.100595. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rosuvastatin	Small molecule	10 mg	Oral
Subject	Rosuvastatin	Small molecule	20 mg	Oral
Comparator	Simvastatin	Small molecule	20 mg	Oral
Comparator	Simvastatin	Small molecule	40 mg	Oral
Background	Ezetimibe	Unknown	10 mg	Oral

Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia

Summary

Timeline

Publications

Drugs

Indications