Effects of L-carnitine administration in patients with elevated Lp(a)levels. - ND

Conditions: Dislipidemic patients with Lp(a)>35 mg/dl
LDL-C<190 mg/dl, TG<500 mg/dl
MedDRA version: 9.1Level: LLTClassification code 10062060

Registration Number: EUCTR2010-022041-19-IT

Lead Sponsor: RostaQuo S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•age between 18 and 75 years •both sexes •Lp(a) > 35 mg/dl •LDL-C<190 mg/dl •TG < 500 mg/dl •informed consent
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•miocardic infarction, angina pectoris, stroke, coronary angioplasty or bypass 6 months before screening visit •history of liver patologies •history of chronic renal insufficiency •previous organ transplantation •previous alcohol or drug abuse •if diabetic, HbA1c=7% •hypersensitivity known or suspected to L-Carnitine and/or its derivatives •treatment with L-Carnitine and/or its derivatives during 3 months before the start of the study. •for female patients: pregnant status known or suspected, ongoing breast nursing.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of the study is the evalutation of the effect induced by L-carnitine on Lp(a) plasma levels in dislipidemic patients.;Secondary Objective: Secondary objectives of the studi are the evalutation of o the effect induced by L-carnitine on complete lipidic profile ad on the inflammatory status, in dislipidemic patients.;Primary end point(s): Primary endpoint is the reduction of Lp(a) plasma levels after 90 days of the treatment under investigation.

Secondary Outcome Measures