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

What Was Tested

In this phase 3 trial, researchers set out to test L-Carnitine.

It had two arms (groups): Experimental Group (experimental) and Control Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Evaluate the safety of the medicines under study.

The combination of L-carnitine + atorvastatin shows fewer incidences in the presence of adverse events attributable to the medicine in comparison to the use of atorvastatin as mono-therapy, in the treatment of dyslipidemia patients.

Material and Methods: Sample Size 120 subjects will be included.

Inclusion Criteria Mexicans between 35 and 75 years of age.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 35 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Mexicans between 35 and 75 years of age. 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.

The full record lists 9 inclusion and 29 exclusion criteria; among the exclusions: 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; subjects who are under anticoagulant treatment, suffer from coagulation disorders, or any circumstance which contraindicates the taking of a blood.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind L-Carnitine study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2018-05-28 with completion listed for 2019-03-01.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Incidence of Treatment-Emergent Adverse Events (safety and tolerability).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.