- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420549
Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia (LANCE)
January 20, 2020 updated by: Ache Laboratorios Farmaceuticos S.A.
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
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 Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
129
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio De Janeiro, Brazil
- CCBR Brasil Centro de Pesquisas e Análises Clínicas
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São Paulo, Brazil
- CEPIC Centro Paulista de Investigação Clínica
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São Paulo, Brazil
- FGM - Clínica Paulista de Doenças Cardiovasculares
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São Paulo, Brazil
- Hospital do Rim e Hipertensão
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São Paulo, Brazil
- Universidade Federal de São Paulo
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Ceará
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Fortaleza, Ceará, Brazil
- Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas- UFC
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Pernambuco
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Recife, Pernambuco, Brazil
- Centro de Pesquisas Médicas Básica e Clínica
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.
Other Names:
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Active Comparator: 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.
|
Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of LDL Cholesterol Levels
Time Frame: Baseline compared to the end of 9 weeks of treatment
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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.
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Baseline compared to the end of 9 weeks of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francisco Fonseca, physician, Universidade Federal de São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
August 18, 2011
First Submitted That Met QC Criteria
August 18, 2011
First Posted (Estimate)
August 19, 2011
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 20, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
- Simvastatin
- Ezetimibe
Other Study ID Numbers
- ACH-TRZ-03(06/11)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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