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

NCT03696940 | Unknown Phase 3

• 1 other identifier: GMX-001-2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Efficacy of experimental treatment by the change in Cholesterol LDL

  Evaluate the change of atorvastatin + l-carnitine vs. atorvastatin alone for dyslipidemia, through change of C-LDL in mg/dl

  6 months

Secondary Outcomes (5)

• Efficacy of experimental treatment by the change in Cholesterol no-HDL

  6 months

• Efficacy of experimental treatment by the change in Total serum Cholesterol

  6 months

• Efficacy of experimental treatment by the change in Triglycerides

  6 months

• Efficacy of experimental treatment by the change in Cholesterol HDL

  6 months

• Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

  6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

2 tablets of: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg

Drug: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg

Control Group

ACTIVE COMPARATOR

2 tablets of: Atorvastatin 10 mg

Drug: Atorvastatin 10mg

Interventions

L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg DRUG

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

Also known as: Experimental Group

Experimental Group

Atorvastatin 10mg DRUG

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

Also known as: Active control group

Control Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mexicans between 35 and 75 years of age.
• Gender indistinct.
• Patient with abnormal lipid profile considered as serum levels of Cholesterol LDL of 100mg/dl or greater, obtained by laboratory parameters.
• Women in fertile stage with a safe, hormonal-free family planning method. A safe planning method includes surgical methods in women, intrauterine device that doesn't release progestines and use of preservative in all their sexual relations.
• Women in fertile stage who don't wish to become pregnant during their participation in the study.
• Post-menopause women or with hysterectomy history.
• Have a fixed and/or mobile telephone and accept to receive calls from the site for study processes.
• Grant their duly informed consent.

You may not qualify if:

• Subject lacking the mental capacity to understand the processes which imply their participation in the study and thus, not capable of granting their participation in a voluntary manner
• History of hypersensitivity to the medicines being studied.
• Daily intake of at least 240 mL of grape juice or sporadic ingestion of 1 liter.
• Potentially fertile women without a safe family planning method, who wish to become pregnant during the study, are already pregnant or in lactation period.
• Having on Globorisk scale for Mexicans, or as an associated risk factor, a high stratification for cardiovascular risk.
• Basal laboratory values with elevation of ALT 1.5 times larger than the upper limit considered normal according to international units.
• Basal laboratory values with elevation of CPK not attributable to physical activity.
• Subjects who are under anticoagulant treatment, suffer from coagulation disorders, or any circumstance which contraindicates the taking of a blood.
• History of acute myocardial infarction, unstable angina, some confirmed coronopathy, arrhythmias, congestive cardiac failure or cerebrovascular disease.
• History of muscular conditions of the genetic type or of rhabdomyolysis in the patient or first degree relative.
• History or diagnose of congenital hepatic disorders, chronic infection by hepatitis virus, hepatitis with fatty liver, alcoholic hepatitis, primary biliary cirrhosis, primary sclerosis, cholangitis or hepatic failure.
• History or diagnose of congenital renal disorders, chronic renal failure, acute renal damage or nephritic syndrome.
• History of infection by Human Immunodeficiency Virus.
• History of Acute or Chronic Pancreatitis.
• History of the following endocrine diseases: non controlled Diabetes Mellitus, lipodystrophy, thyroid disorders, Cushing Syndrome and or Polycystic Ovary Syndrome.

Sponsors & Collaborators

• Laboratorios Grossman, S.A.: lead
• Instituto Nacional de Salud Publica, Mexico: collaborator

Study Sites (1)

Laboratorios Grossman Sa

Mexico City, 04040, Mexico

Location

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Related Links

• World Health Organization: Global Status report on non-communicable diseases 2014.
• Protocolo clínico para el diagnóstico y tratamiento de las Dislipidemias. CENAPRECE, Secretaría e Salud, D.F. México.
• Treatment of lipids (including hypercholesterolemia) in secondary prevention.
• Organization for Economic Cooperation and Development.

MeSH Terms

Conditions

Dyslipidemias

Interventions

Carnitine; Tablets; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Aurelio Cruz Valdez, PhD

  Instituto Nacional de Salud Pública

  PRINCIPAL INVESTIGATOR

• José Flores Figueroa, PhD

  JM Research, SC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Simple Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Longitudinal

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 5, 2018
• Study Start: May 28, 2018
• Primary Completion: March 1, 2019
• Study Completion: August 31, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)