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

NCT03696940 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Dyslipidemias
  • Cardiovascular Risk Factor

Interventions

DRUG

L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg

Oral administration of 2 tablets of atorvastatin 10 mg (each one) every 24 hours for 6 months.

DRUG

Atorvastatin 10mg

Oral administration of 2 tablets atorvastatin 10 mg (each one) every 24 hours for 6 months.

Sponsors & Collaborators

  • Instituto Nacional de Salud Publica, Mexico

    collaborator OTHER

  • Laboratorios Grossman, S.A.

    lead INDUSTRY

Principal Investigators

  • Aurelio Cruz Valdez, PhD · Instituto Nacional de Salud Pública

  • José Flores Figueroa, PhD · JM Research, SC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2019-03-01
Completion
2019-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696940 on ClinicalTrials.gov