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

HELP Pharmaceuticals S.A.0 个研究点开始时间: 2007年2月15日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•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).

发起方

HELP Pharmaceuticals S.A.