CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 129 enrolled
Drug / intervention
Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation. +1 moredrug
Likely dose
Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01420549
NCT01420549Phase 3Completed
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Phase III, Multicenter, Randomized, Open-label, Comparative Study to Evaluate Efficacy and Safety of Rosuvastatin + Ezetimibe Versus Simvastatin + Ezetimibe in High Risk Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Ache Laboratorios Farmaceuticos S.A.·interventional·Posted Aug 19, 2011·Updated Jan 22, 2020

In Brief

A Phase 3 clinical trial evaluating Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation. and Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation. for Hypercholesterolemia and Dyslipidemia. Completed, enrolled 129 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Dyslipidemia
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2011
Enrollment StartMar 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.9 years ago

Interventions

Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.drug

Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.

Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.drug

Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.