Efficacy and Safety of FDC in High Risk Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (LANCE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Ache Laboratorios Farmaceuticos S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01420549
First received: August 18, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

The purpose of this study is to determine the non-inferiority between two different FDC, measuring LDL-Cholesterol levels, in high risk patients by NCEP-ATP III, with primary hypercholesterolemia or mixed dyslipidemia.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Drug: Rosuvastatin + Ezetimibe
Drug: Simvastatin + Ezetimibe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Multicenter, Randomized, Open-label, Comparative, Parallel Group Study of the Efficacy and Safety of Rosuvastatin + Ezetimibe Versus Simvastatin + Ezetimibe in High Risk Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Changes in LDL-Cholesterol level [ Time Frame: Baseline compared to the end of 9 weeks of treatment ] [ Designated as safety issue: No ]
    It is considered successful treatment the patients who achieve the LDL-C level < 100 mg/dl.


Secondary Outcome Measures:
  • Changes in HDL, triglycerides and apolipoprotein B levels [ Time Frame: Baseline compared to the end of 9 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety descriptive about occurence of adverse events, evaluation of results of general physical examination. [ Time Frame: Will be evaluated during whole study, at the baseline and after 9 weeks of treatment ] [ Designated as safety issue: Yes ]
    Collection of safety data throughout the whole study period


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 01
Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according with titration.
Drug: Rosuvastatin + Ezetimibe
Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according with titration.
Active Comparator: Group 02
Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according with titration.
Drug: Simvastatin + Ezetimibe
Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according with titration.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes, aged between 18 and 70 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
  • Confirmed diagnosis of primary hypercholesterolemia;
  • Confirmed diagnosis of mixed dyslipidemia;
  • Liver transaminases ≤ 2 x upper limit of normal with no active liver disease;
  • Creatinine kinase (CK) less or equal the upper limit of normality;
  • Patients should not have clinically significant comorbidities, which may interfere in the evaluation of study;
  • Patients who is willing to maintain a cholesterol-lowering diet throughout the study;
  • Patients need to agree in discontinue the previous medication for hypercholesterolemia treatment and switch to the study medication.
  • Patients with primary hypercholesterolemia who have LDL-C > 160 mg/dl and < 220 mg/dl; and triglyceride (TG) concentration < 350 mg/dl

Exclusion Criteria:

  • Heart failure class III or IV (NYHA);
  • Blood dyscrasia;
  • Unstable angina pectoris;
  • Myocardial infarction in the last 3 months;
  • Planning for CABG, peripheral or carotid percutaneous intervention for the next 90 days;
  • Renal insufficiency (estimated GFR < 30 ml/min/m2);
  • Liver transaminases > 2 x upper limit of normal;
  • Asian patients or kinship asian;
  • History of alcoholism or drug abuse;
  • Patients with comorbidities that hinder the interpretation of results or contraindicate the lipid-lowering therapy [uncompensated hypothyroidism (TSH > 8 mUI/mL); uncompensated diabetes (HbA1c > 8%); active hepatic disease; antiretroviral therapy, neoplasm (except for adequately treated squamous cell skin cancer within the past 5 years), concomitant immunosuppressive therapy (transplanted and rheumatic disease).
  • Non-compensated hypertension (BP ≥ 160/100 mm Hg);
  • Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
  • Woman in pregnancy or lactation period;
  • Hypersensibility to ezetimibe or rosuvastatin, or any component of these medications;
  • Participation in last one year of clinical protocols, unless it can be direct benefit to patient;
  • Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01420549     History of Changes
Other Study ID Numbers: ACH-TRZ-03(06/11)
Study First Received: August 18, 2011
Last Updated: August 18, 2011
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Hypercholesterolemia
Dyslipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Rosuvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014