Dislipidemic patients with Lp(a)>35 mg/dl
Conditions
Interventions
Pharmaceutical Form: Oral solution
INN or Proposed INN: Levocarnitine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Oral solution
Sponsors
RostaQuo S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •age between 18 and 75 years •both sexes •Lp(a) > 35 mg/dl •LDL-C=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed