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

NCT01420549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-01-22

Study results available
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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.

Conditions

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Francisco Fonseca, physician · Universidade Federal de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420549 on ClinicalTrials.gov