Type 2 diabetic patients, as defined by the WHO without CVD and with CVD (Cardiovascular disease), with combined hyperlipidemia. MedDRA version: 9.1 Level: LLT Classification code 10027763 Term: Mixed hyperlipidemia
Conditions
Interventions
Product Name: Fenofibrate/Pravastatin 160-40mg
Product Code: FENOPRA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fenofibrate
CAS Number: 49562-28-9
Concentration unit: mg milligram(s)
Conc
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria : · Male or female, aged 18 years and older · Type 2 diabetic patients as defined by the WHO without CVD and with CVD · Patients presenting a known combined hyperlipidemia (to be documented by physician) · Patients following a standardized diet for at least three months before the selection visit and to be maintained stable throughout the study · Able to comply with all study procedures · 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 Inclusion criteria : · Patients with non-HDL-C > or = 130 mg/dl (3.36 mmol/l) [or LDL C > or =100 mg/dl (2.6 mmol/l)] and without CVD, or non-HDL-C > or =100 mg/dl (2.59 mmol/l) [or LDL-C> or = 70 mg/dl (1.8 mmol/l)] and with CVD, at the laboratory sample taken one week before the randomisation visit · TG > or =150 mg/dl (1.7 mmol/l) and =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 [hepatocellular insufficiency, chronic or active liver disease, biliary tract disease, sustained elevation of serum liver enzymes (simultaneous ASAT/SGOT and ALAT/SGPT > 2x ULN at laboratory sample B1 or B2)] · CPK > 3x ULN at laboratory sample B1 or B2 · Abnormal renal function (clearance of creatinine 15 mg/l at laboratory sample B1 or B2) or any renal disease likely to lead to renal dysfunctions · Patients who had an acute cardiovascular episode within the 3 months previous 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· Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease · 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 · Patients with any sensitivity or allergy to any of the products used within this clinical trial: known hypersensitivity to HMG-COA reductase inhibitors, fibric acid derivatives or ezetimibe · Uncontrolled primary hypothyroidism · Uncontrolled diabetes with HbA1c > 8.5% at laboratory sample B1 or B2 · Diabetes requiring insulin · Use of any of the prohibited medication as detailed in the non-permitted medication section · 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 a personal or family history of hereditary muscle disease · Patients with poor cognitive function · Participation in any other clinical trial within 3 months before the selection visit · Childbearing potential woman not using an appropriate contraceptive method, pregnant or breastfeeding woman · Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force · Participation in any other trials with the fenofibrate-pravastatin 160-40 mg SMB product · Compliance <80% during the run-in phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the superiority of the efficacy of Fenofibrate 160mg/Pravastatin 40mg combination versus Simvastatin 20 mg, in type 2 diabetic patients without CVD and with combined hyperlipidemia and to describe the safety of the combination. - To demonstrate the superiority of the efficacy of Fenofibrate 160mg/Pravastatin 40mg combination + Ezetimibe 10 mg versus Simvastatin 20 mg + Ezetimibe 10 mg, in type 2 diabetic patients with CVD and with combined hyperlipidemia and to describe the safety of Fenofibrate 160mg/Pravastatin 40mg combination + Ezetimibe 10 mg. These two objectives will be demonstrated by an evaluation of the mean percent changes in plasma non-HDL cholesterol levels at the end of the efficacy period compared to baseline.;Secondary Objective: · To evaluate the percentage of patients who achieve the therapeutic goals with regards to non-HDL cholesterol and LDL-C levels at the end of the efficacy period, as defined in the NCEP ATP III · To assess and compare the evolution of the following lipid parameters: LDL-C, HDL-C, TG, total cholesterol at the end of the efficacy period · To assess and compare the evolution of ApoA1 and ApoB levels, and of the ratio ApoB/ApoA1 at the end of the efficacy period · To evaluate the changes in CRP values, fibrinogen values and homocystein values at the end of the efficacy period · To compare the safety profiles of Simvastatin 20 mg and Fenofibrate 160 mg/Pravastatin 40 mg combination with and without Ezetimibe during the 12-week efficacy period, and to describe the safety profile of Fenofibrate 160 mg/Pravastatin 40mg combination with and without Ezetimibe 10 mg during the 12-week safety period. ;Primary end point(s): Primary Efficacy endpoints : · Mean percent change in plasma non-HDL cholesterol levels at the end of the efficacy period compared to the baseline Secondary Efficacy endpoints : · Percentage of patients who achieve the therapeutic goals concerning the non-HDL-C and LDL-C levels at t | — |
Countries
France, Germany, Hungary
Outcome results
None listed