Dyslipidemia with uncontrolled elevated triglycerides MedDRA version: 9.1 Level: LLT Classification code 10058110 Term: Dyslipidemia
Conditions
Interventions
Product Name: V0002 CA
Product Code: V0002 CA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: omega-3-acid triglycerides
Current Sponsor code: V0002 CA
Concentration unit: g gram(s)
Concentrat
Sponsors
PIERRE FABRE MEDICAMENT represented by Institut de Recherche Pierre Fabre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: _ Male or female outpatients, aged 18 to 75 years inclusive _ Having given their written informed consent _ With a Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Criteria relative to the target disease : _ Triglycerides above 10g/l _ Menopausal women presenting flushes Criteria relative to treatments : _ History of allergy or hypersensitivity reaction to the study medication and their excipients _ History of serious allergy or hypersensibility reaction to any medication _ Known contraindication to the use of HMG CoA reductase inhibitor (statin) _ Treatment by a lipid lowering agent other than an HMG CoA reductase inhibitor (statin) _ Any other treatment likely to interfere with lipid metabolism _ Patients treated by an anticoagulant drug _ Patients treated by aspirin and likely to change their dose (continuous low dose of aspirin ( 145 mmHg or DBP > 95 mmHg) under blood pressure treatment _ Uncontrolled hypothyroidism defined as TSH > 2 x the upper limit of normal (ULN) - Thyroid dysfunction controlled for at least 6 months prior to screening is permitted _ Abnormal liver function (hepatocellular insufficiency, chronic or active liver disease, biliary tract disease, sustained elevation of serum liver enzyme ALAT > 2X ULN) _ CPK >3x ULN _ Abnormal renal function (clearance of creatinin 15mg/l or any renal disease likely to lead to renal dysfunctions) _ HbA1C > 9 % _ Type 1 diabetes mellitus, severe cardiac events within the previous 3 months, secondary causes of hyperlipidemia _ Patients with known hemorrhagic risk (planned surgical intervention, raised erythrocyte sedimentation rate, thrombocytopenia) _ Arterial bleeding _ History of unstable angina or acute myocardial infarction _ Active peptic ulcer disease _ Personal or familial history of muscular troubles / myalgia _ History of muscular toxicity provoked by lipid lowering agent (Fibrate and/or statin) _ History of presence of any organic disorder likely to modify absorption, distribution or elimination of the medication _ Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer _ Patients likely to be non-compliant _ Patients who have already been included in this study or who are participating in another clinical trial with medicines _ Patients having received any other investigational agent within 3 months before randomization _ Patient with any significant history of non-compliance to medical regimens or likely to be non-compliant or with inability to grant reliable informed consent _ Patient not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force _ Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study _ Patients who have received more than 4500 euros as indemnities for his participation to other clinical trials, including the present trial, within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of V0002 CA 1 g at 3 capsules /day on preventing niacin-induced flushing promoted by Niaspan® administration;Secondary Objective: _ To assess efficacy of the treatment combination on LDL-C, HDL-C, Triglycerides during 4 weeks in comparison to placebo _ To assess efficacy of the combination on other lipoproteins, apolipoproteins, and biological markers during 4 weeks in comparison to placebo _ To evaluate clinical and biological tolerability;Primary end point(s): Efficacy criteria : Primary : _ Global intensity of flush, (flush being defined as the presence of at least one of the 4 following symptoms: redness, warmth, tingling, itching) at the first day of each dose increase of Niaspan®, following D1, D8, D15, D22 Secondary : Lipids : _ Total Cholesterol, LDL-C, HDL-C, non-HDL-C, Triglycerides _ Apolipoproteines: Apo A1, Apo A2, Apo B, Apo C3, Lp(a), fibrinogen, homocystein, CRP Niaspan®-induced flushes : _ Mean global intensity of flush, including redness, warmth, tingling or itching at each weekly period of escalating Niaspan® dose _ Mean global intensity of flush, including redness, warmth, tingling or itching over the 28 day treatment period _ Presence or not of daily flushing symptoms, including redness, warmth, tingling or itching _ Number of daily flushing symptoms, including redness, warmth, tingling or itching _ Duration of the longest daily flushing symptoms, including redness, warmth, tingling or itching _ Intensity of daily flushing-related to redness _ Intensity of daily flushing-related to warmth _ Intensity of daily flushing-related to tingling _ Intensity of daily flushing-related to itching _ Global Flush Score “GFS” calculated as daily number of flushes multiplied with the daily global intensity of flush _ Number of patients withdrawn from study due to flushes will be compared between treatment groups at the end of the study and on the period of each dose of Niaspan® Safety criteria : _ Adverse events, clinical exa | — |
Countries
France
Outcome results
None listed