Efficacy and safety study comparing PRAVAFENIX versus atorvastatin 20 mg in high coronary heart disease risk patients with mixed dyslipidaemia

• Conditions: mixed dyslipidaemia; MedDRA version: 17.0Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 17.0Level: PTClassification code 10070901Term: Diabetic dyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 17.0Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000575-17-HR
• Lead Sponsor: ABORATOIRES SMB S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-03
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

•Patients with HDL-C < 40 mg/dl for male and HDL-C< 50 mg/dl for
female at the laboratory sample taken one week before the
randomization visit (B2)
•Patients with TG > or equal to 150 mg/dl and < or equal to 600 mg/dl at the laboratory
sample taken one week before the randomization visit (B2)
•Patients with LDL-C < 100 mg/dl at the laboratory sample taken one
week before the randomization visit (B2)
•Patients still respecting the other selection criteria
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 408
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

-Secondary or iatrogenic dyslipidaemia
-Dyslipidaemia 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 < 60 ml/min) at the selection and randomization
visits
-Severe hepatic impairment including biliary cirrhosis or active liver
disease including unexplained persistent elevations in liver function
tests (including ASAT/SGOT or ALAT/SGPT elevation exceeding 3X ULN)
at the selection and randomization visits
-Gallbladder disease
-Chronic or acute pancreatitis
-Patients who had an acute cardiovascular episode within the 3 months
prior to the start of the trial, or with a history of coronary angioplasty
with mounting of a stent within the past 6 months
-Uncontrolled hypertension (SBP > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the present study is to demonstrate the non-inferiority<br>of the efficacy of Fenofibrate 160 mg/Pravastatin 40 mg fixed<br>combination (PRAVAFENIX®) versus Atorvastatin 20 mg, in high CHDrisk<br>patients with mixed dyslipidaemia not at goals on Atorvastatin 10<br>mg regarding TG (between 150 mg/dl and 600 mg/dl) and HDL-C (< 40<br>mg/dl for male and < 50 mg/dl for female).;Secondary Objective: To compare and describe the safety of the Fenofibrate 160<br>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<br>levels at the end of the study compared to baseline;Timepoint(s) of evaluation of this end point: at the end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the:<br>•Mean percent change of the following lipid parameters levels: LDL-C,<br>HDL-C, TG, total cholesterol<br>•Mean percent change of Apo A1 and Apo B<br>•Mean percent change of Apo B/Apo A1 ratio;Timepoint(s) of evaluation of this end point: at the end of study