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

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ClinicalTrials.gov Identifier: NCT01420549
Recruitment Status : Completed
First Posted : August 19, 2011
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemia Drug: 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. Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


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.
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.
Other Name: Lance

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.
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.
Other Name: Vytorin




Primary Outcome Measures :
  1. Reduction of LDL Cholesterol Levels [ Time Frame: Baseline compared to the end of 9 weeks of treatment ]
    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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420549


Locations
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Brazil
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
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
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Principal Investigator: Francisco Fonseca, physician Universidade Federal de São Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01420549    
Other Study ID Numbers: ACH-TRZ-03(06/11)
First Posted: August 19, 2011    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Hypercholesterolemia
Dyslipidemia
Additional relevant MeSH terms:
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Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors