mixed dyslipidaemia MedDRA version: 16.0 Level: PT Classification code 10058108 Term: Dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 16.0 Level: PT Classification code 10070901 Term: Diabetic dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 16.0 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: PRAVAFENIX
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FENOFIBRATE
CAS Number: 49562-28-9
Other descriptive name: FENOFIBRATE
Concentration unit: mg milligram(s)
Concentration
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with HDL-C 150 mg/dl and =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: -Secondary or iatrogenic dyslipidaemia -Hyperlipidaemia type I-IIa-IV-V -Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed CPK elevation > 5X ULN under previous statin treatment or at the selection and randomization visits -Moderate to severe renal impairment (defined as an estimated creatinine clearance 160 mmHg or DBP > 95 mmHg) under blood pressure treatment -Uncontrolled primary hypothyroidism -Uncontrolled diabetes with HbA1c > 8.5% -Diabetes requiring insulin -Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease -Non adherence to a stable standardized diet during the study -Patients with high alcohol consumption (above 21 beverages per week or with a recent history of alcoholism : one alcoholic beverage is defined as 30 ml distilled spirits, 120 ml wine, or 330 ml beer) -Patients with poor cognitive function -Hypersensitivity to the active substances or to any of the excipients -Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen -Use of any of the prohibited medication as detailed in the non-permitted medication section -Participation in any other clinical trial within 3 months before the selection visit -Woman of childbearing potential not using an appropriate contraceptive method -Pregnancy and breast feeding -Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force -Compliance <80% during the run-in phase -Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study and likely to jeopardize the planned termination of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present study is to demonstrate the non-inferiority of the efficacy of Fenofibrate 160 mg/Pravastatin 40 mg fixed combination (PRAVAFENIX®) versus Atorvastatin 20 mg, in high CHD-risk patients with mixed dyslipidaemia not at goals on Atorvastatin 10 mg regarding TG (between 150 mg/dl and 600 mg/dl) and HDL-C (< 40 mg/dl for male and < 50 mg/dl for female).;Secondary Objective: To compare and describe the safety of the Fenofibrate 160 mg/Pravastatin 40 mg fixed combination versus Atorvastatin 20 mg.;Primary end point(s): To evaluate the mean percent changes in plasma non-HDL cholesterol levels at the end of the study compared to baseline;Timepoint(s) of evaluation of this end point: at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the: • Mean percent change of the following lipid parameters levels: LDL-C, HDL-C, TG, total cholesterol • Mean percent change of Apo A1 and Apo B • Mean percent change of Apo B/Apo A1 ratio ;Timepoint(s) of evaluation of this end point: at the end of study | — |
Countries
Bulgaria, Croatia, Latvia, Macedonia, the former Yugoslav Republic of
Contacts
Public ContactCLINICAL DEPARTMENT
LABORATOIRES SMB S.A.
Outcome results
None listed