Dyslipidemia MedDRA version: 14.1 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Cholib
Pharmaceutical Form: Film-coated tablet
CAS Number: 79902-63-9
Other descriptive name: SIMVASTATIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Abbott Laboratories Ireland Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Either gender (tentatively 50% females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence. 2.= 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products, 2.Pregnant or lactating women, 3.Unable or unwilling to comply with the protocol and the recommended diet, 4.Likely to withdraw from the study before its completion, 5.Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1, 6.Associated diseases or conditions: ? Known active or chronic hepatobiliary or liver diseases (including biliary cirrhosis and unexplained persistent liver function abnormality e.g. persistent elevations in serum transaminases), ? Known cholelithiasis (except in case of cholecystectomy), ? Current chronic pancreatitis or identified risk or past history of acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia, ? Known current alcoholism or alcohol intake greater than 21 units per week, ? Medical history of myositis, myopathy or rhabdomyolysis, ? Known abnormal thyroid hormone levels (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for inclusion), ? Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ? Congestive heart failure NYHA Class III or IV (class III marked limitation of physical activity, class IV inability to carry out any physical activity without discomfort), ? Uncontrolled cardiac arrhythmias, ? Myocardial infarction, coronary bypass surgery or angioplasty within 3 months preceding inclusion in the study, ? Unstable or severe peripheral artery disease within 3 months preceding inclusion in the study, ? Unstable angina pectoris within 3 months preceding inclusion in the study, ? Any other severe pathology such as cancer or mental illness or degenerative disease that would limit study evaluation or participation, ? Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): % change in TG, high density lipoprotein cholesterol (HDL-C) and LDLC from baseline to 12 weeks of treatment;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment and after 12 weeks of treatment;Main Objective: To compare the efficacy of the two fixed-combinations (FC) - fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing triglycerides (TG) and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol LDL-C versus fenofibrate 145 mg in subjects with mixed dyslipidemia (type IIb) at high or very high risk of cardiovascular disease after 12 weeks of treatment.;Secondary Objective: -To compare the efficacy of fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet versus simvastatin monotherapy and fenofibrate 145 mg monotherapy after 12 weeks of treatment on non-HDL-C, total cholesterol (TC), apolipoprotein AI (ApoAI), apolipoprotein B (ApoB), high-sensitivity C-reactive protein (hsCRP). -To compare the percentage of subjects meeting target levels of lipids (according to very high or high risk) after 12 weeks of treatment. -To evaluate the safety of fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet to simvastatin 20 mg or 40 mg, and fenofibrate 145 mg over 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) % change from baseline to 12 weeks of treatment in non-HDL-C, Total Cholesterol (TC), apolipoprotein AI (ApoAI) and apolipoprotein B (ApoB) 2) Change from baseline to 12 weeks of treatment in high sensitivity C-reactive protein (hsCRP) 3) % of subjects meeting target levels of lipids (according to very high or high risk) after 12 weeks of treatment;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment and after 12 weeks of treatment | — |
Countries
Argentina, Czech Republic, Mexico, Poland, Russian Federation
Contacts
Public ContactDr Jean-Claude Ansquer
Abbott Healthcare Products B.V
Outcome results
None listed