This study will evaluate the safety and efficacy of combined treatment with L- Carnitine and Simvastatin in reducing the Lipoprotein (a) and triglyceride level of patients with mixed hyperlipidemia. It can also include recently diagnosed patients wih diabetes mellitus type 2, who receive only dietary treatment. Lipoprotein (a) and hyperlipidemia are known risk factors for cardiovascular heart disease. MedDRA version: 8.1 Level: LLT Classification code 10027763 Term: Mixed hyperlipidemia
Conditions
Interventions
Trade Name: Inestom
Pharmaceutical Form: Oral solution
INN or Proposed INN: L-Carnitine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the plac
Sponsors
HELP Pharmaceuticals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients capable of reading and understanding the Informed Consent Form. 2. Patients who signed the Informed Consent Form. 3. Patients with mixed hyperlipidemia (LDL> 160mg/dL, TG> 200mg/dL and Lp(a)> 20mg/dL[> 0.71mmol/L]) or/and recently diagnosed patients with diabetes mellitus type 2 [during the last 6 months] according to the American Diabetes Association, who are receiving only dietary treatment. 4. Outpatient subjects of both genders, aged between 18 and 65 years old (margins included). 5. Patients willing and able to attend the study program, according to its time limitations 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have taken part in another L- Carnitine study in the past. 2. Patients who receive non permitted drug treatment or simultaneous drug treatment: _ any lipid lowering drug (simvastatin included) during the past 4 weeks before the trial initiation. _ any diuretic drug during the past 2 months. _ any B- blocker regimen during the past 4 weeks. _ drugs that interfere with the mitochondrial metabolism (e.g. benzodiazepines, glivencamide, zidovoudine). _ thyroxine, regardless of the duration. _ anticoagulants (dikoumarole), regardless of the duration. 3.Patients with renal (serum creatinine> 1,4 mg/dL, preteinuria> 0,5 gr/ 24hours), neoplasmatic or hepatic (SGOT, SGPT > 3 x upper normal limit) disease. 4.Patients with hypothyroidism. 5.Patients with medical history of epileptic convulsions or patients receiving treatment for epilepsy 6.Patients with history of serious allergy or hypersensitivity in the medicinal product, or patients with known hypersensitivity in simvastatin or L-carnitine 7.Female patients that are pregnant or in lactation or patiens who use oral contraceptives. 8.Female patients with reproductive potential who do not use effective contraception (As effective contraception is defined the oral/systematic contraception, surgical sterilisation, endometrial devices, contraceptive diaphragm in combination with sperm killer or condom for the male partner in combination with sperm killer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to estimate the efficacy and safety of combined treatment with L- carnitine and simvastatin in reducing the serum lipoprotein (a) and tiglyceride levels in patients with mixed hyperlipidemia, after 12 weeks of treatment.;Secondary Objective: To (voluntary) estimate the efficacy and safety of combined treatment with L- carnitine and simvastatin in reducing the serum lipoprotein (a) and triglyceride levels in patients with mixed hyperlipidemia, after 24 weeks of treatment. The assesement of safety and tolerance of the drug combination during the full study duration. ;Primary end point(s): Reduction of serum lipoprotein a or/ and serum triglycerides levels after a 12 week period of treatment with the study's drug combination (L-carnitine and simvastatin). Assessment of drug safety and tolerance. | — |
Countries
Greece
Outcome results
None listed