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

NCT ID: NCT01420549

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

Brief 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.

Detailed Description

The primary efficacy variable was the percentage of LDL-C variation at the end of nine weeks of treatment, compared to baseline (pre-randomization), in participants who achieved LDL <100 mg/dL were considered to have been successfully treated.

Conditions

Hypercholesterolemia; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin + Ezetimibe

Participants received Rosuvastatin 10 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was \<100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Rosuvastatin 20 mg+ Ezetimibe 10mg tablet orally once daily for more 4 weeks.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Simvastatin + Ezetimibe

Participants received Simvastatin 20 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was \<100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Simvastatin 40 mg + Ezetimibe 10mg tablet orally once daily for more 4 weeks.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lance; Vytorin

Eligibility Criteria

Inclusion Criteria

• Male and female participants aged 18 to 80 years;
• Participants diagnosed with primary hypercholesterolemia or mixed dyslipidemia;
• Participants must not have other clinically significant comorbidities that may interfere with study evaluations;
• Participants able to understand and adhere to the therapeutic scheme and to attend the study visits;
• Participants who agree to maintain a low cholesterol diet throughout the study;
• Participants who agree to discontinue previous medication for hypercholesterolemia treatment throughout the study;
• Participants with hypercholesterolemia or mixed dyslipidemia with the following laboratory test results on the baseline visit: LDL-C level >130 mg/dl if were receiving prior treatment with statins; or LDL-C level >100 mg/dl if were receiving prior treatment with first generation statins; or LDL ≥160 mg/dL and ≤220 mg/dL and triglycerides ≤350 mg/dL if were not in prior treatment with statins.
• Female participants in reproductive age with negative serum beta-hCG test result in the baseline visit who agree to use acceptable contraceptive methods (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch, tubal ligation or female participants who declare to perform non reproductive sexual practices); except surgically sterile (for example oophorectomy and hysterectomy), surgical sterilization or of the partner; or postmenopausal for at least one year;
• Participants with laboratorial test results after treatment with Simvastatin 20 mg for four weeks with LDL-C level ≥100 mg/dl.

Exclusion Criteria

• Heart failure class III or IV (NYHA- New York Heart Association);
• Blood dyscrasia;
• Unstable angina pectoris;
• Myocardial infarction in the last 3 months;
• Planning for CABG (coronary artery bypass graft), peripheral or carotid percutaneous intervention for the next 90 days;
• Renal insufficiency: estimated Glomerular Filtration Rate (GFR) < 30 ml/min/m2;
• History of alcoholism that, at the investigator's discretion, could compromise the drug treatment compliance;
• Participants with comorbidities that hinder the interpretation of results or contraindicate the lipid-lowering therapy [uncontrolled hypothyroidism (thyroid-stimulating hormone [TSH] > 8 mUI/mL); uncontrolled diabetes (Hemoglobin A1c [HbA1c] > 8%); active hepatic disease; antiretroviral therapy for HIV, neoplasm (except for adequately treated skin cancer within the past 5 years), concomitant immunosuppressive therapy (transplant receivers and rheumatic disease);
• Uncontrolled systemic arterial hypertension;
• Hypersensitivity to any component of the investigational product;
• Participant who has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to the patient;
• Any observational finding (clinical/ physical evaluation), laboratory abnormality, disease or therapy that is interpreted by the investigator as a risk to the research participant's participation in the clinical trial;
• Aspartate transaminase (AST) or alanine aminotransferase (ALT) more than two times the normal upper limit of the central laboratory reference range after treatment with Simvastatin 20 mg for four weeks;
• Creatine phosphokinase (CPK) more than three times the normal upper limit of the central laboratory reference range after treatment with Simvastatin 20 mg for four weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Fonseca, physician

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Locations

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas- UFC

Fortaleza, Ceará, Brazil

Centro de Pesquisas Médicas Básica e Clínica

Recife, Pernambuco, Brazil

CCBR Brasil Centro de Pesquisas e Análises Clínicas

Rio de Janeiro, , Brazil

CEPIC Centro Paulista de Investigação Clínica

São Paulo, , Brazil

FGM - Clínica Paulista de Doenças Cardiovasculares

São Paulo, , Brazil

Hospital do Rim e Hipertensão

São Paulo, , Brazil

Universidade Federal de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32904162 (View on PubMed)

Other Identifiers

ACH-TRZ-03(06/11)

Identifier Type: -

Identifier Source: org_study_id