A multicentre, randomised, double-blind, controlled with placebo clinical trial with parallel groups, for the evaluation of the efficacy and safety of combined treatment with L-carnitine and simvastatin in the reduction of serum lipoprotein (a) or/and triglycerides in patients with mixed hyperlipidemia
- Conditions
- 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: 8.1Level: LLTClassification code 10027763Term: Mixed hyperlipidemia
- Registration Number
- EUCTR2006-006328-20-GR
- Lead Sponsor
- HELP Pharmaceuticals S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>The assesement of safety and tolerance of the drug combination during the full study duration.<br>;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.
- Secondary Outcome Measures
Name Time Method