Overview

Clinical Trial to Evaluate the Efficacy of a Dyslipidemic Therapy in Mexican Population

Status:
Unknown status
Trial end date:
2019-08-31
Target enrollment:
Participant gender:
Summary
Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy to dislipydemias in mexican adult population. This trial includes homogeneus populations that could be comparable by their disease condition, biologic characteristics and sociodemographics characteristics. 2 Treatment groups: Experimental Group: Oral Administration of L-carnitine (1g) + Oral Atorvastatin (20mg), every 24 hours for 6 months. Active control group: Oral Administration of Atorvastatin 20mg every 24 hours for 6 months. Sample Size: 120 subjects, females or males between 35 to 75 years old. Laboratory tests: Hematic biometry, quimical blood components, electrocardiogram and pregnancy urinary test.
Phase:
Phase 3
Details
Lead Sponsor:
Laboratorios Grossman, S.A.
Collaborator:
Instituto Nacional de Salud Publica, Mexico
Treatments:
Atorvastatin
Atorvastatin Calcium