High vascular risk patients with combined hyperlipidemia
Conditions
Interventions
Product Name: FENOFIBRATE
Product Code: FENOPRA
Pharmaceutical Form: Capsule*
INN or Proposed INN: FENOFIBRATE
CAS Number: 49562-28-9
Current Sponsor code: FENOPRA
Concentration unit: mg milligram(s)
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female, 18 years and older High vascular risk patients according to the NCEP ATP III definitions with combined hyperlipidemia Patients following a standardized diet for at least three months before the screening visit to be maintained stable throughout the study. Patients taking a statin therapy for at least 8 weeks (stable dose) at the selection visit Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form If the patient is female and of childbearing potential, she must be using an efficient mean of birth control, as determined by the investigator and provide a negative serum pregnancy test at the selection visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Secondary or iatrogenic dyslipidemia Hyperlipidemia type I-IIa-IV-V Abnormal liver function CPK > 3x ULN Abnormal renal function Uncontrolled hypertension, as defined by SBP > 160 mm Hg or DBP > 95 mmHg under blood pressure treatment Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease Uncontrolled primary hypothyroidism Uncontrolled diabetes with Hb1Ac > 8.5% Use of any of the prohibited medication as detailed in the concomitant medication section Patients with poor cognitive function Participation in any other clinical trial within 3 months of the selection visit Childbearing potential woman not using an appropriate contraceptive method, pregnant or breastfeeding woman Patients with a biliary tract disease Patients with high alcohol consumption or with a recent history of alcoholism Patients with a personal or family history of hereditary muscle disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the safety of the combination Fenofibrate/Pravastatin 160-40 mg in high vascular risk patients as defined in the NCEP ATP III with combined hyperlipidemia : -Adverse events, physical examination and laboratory evaluation assessed in all patients included in the study -Incidence of myopathy and/or rhabdomyolysis -Increase of transaminase levels -Increase of CPK -Increase of creatinemia and decrease of creatinine clearance -Vital signs -Withdrawals or drop-out rate ;Secondary Objective: To evaluate some efficacy parameters as: - Mean percent changes in plasma non-HDL cholesterol levels - Percentage of patients who achieve the therapeutic goals concerning the non-HDL and LDL levels, as defined in the NCEP ATP III - Evolution of the LDL levels - Evolution of the following other lipidemic parameters levels: HDL, TG, total cholesterol - Evolution of Apo A1, Apo B levels - Evolution of C Reactive Protein (CRP) values - Evolution of Fibrinogen values - Differences in estimated cardiovascular risk for myocardial infarction (PROCAM risk calculator).;Primary end point(s): Safety profile will be assessed as the primary criteria: - Adverse events - Apparition of myopathy and/or rhabdomyolysis - Increase of transaminase levels (> threefold the upper normal limit) - Increase of CPK (> fivefold the upper normal limit) - Increase of creatinemia and decrease of creatinine clearance - Vital signs - Withdrawals or drop-out rate | — |
Countries
Czech Republic
Outcome results
None listed