E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027763 |
E.1.2 | Term | Mixed hyperlipidemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |