Evaluation of Cilostazol in Combination With L-Carnitine

What Was Tested

This registered phase 4 trial tested L-Carnitine.

A second purpose of the study is to see if L-carnitine is absorbed into the blood stream.

It had two arms (groups): Cilostazol + L-Carnitine (active comparator) and Cilostazol + Placebo (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Peripheral Artery Disease (PAD) is a narrowing of the blood vessels that supply the leg with blood.

It is caused by atherosclerosis (hardening of the arteries).

Muscles require oxygen carried by the blood.

When the leg muscles do not get enough blood and oxygen, this can cause pain, cramping, fatigue, and/or discomfort in the leg muscles during walking or exercise.

Who Took Part

The registry lists 164 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

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

Examples of who could join: The subject is \>40 years old. The subject has a diagnosis of Intermittent Claudication (IC) due to Peripheral Artery Disease (PAD). Symptoms of Intermittent Claudication (IC)must be stable for at least 3 months prior to Screening 1. Peak Walking Time (PWT) of ≥ 1 to ≤ 12 minutes on a Gardner protocol at Screening 2. The subject is able to comply with scheduled visits, treatment plan and laboratory tests.

The full record lists 11 inclusion and 33 exclusion criteria; among the exclusions: evidence of critical limb ischemia (cli) (e.g., ischemic rest pain or ischemic ulceration); the subject has had a major amputation of the leg or any other amputation that limits walking ability; the subject has diabetes mellitus type 1 or poorly controlled diabetes mellitus type 2 (hemoglobin a1c (hba1c) \> 10).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-09 with completion listed for 2010-11.

It ran at 24 sites in United States (24).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Change From Baseline in Peak Walking Time (PWT) at Day 180 (time frame: Baseline, Day 180).

It also tracked 6 secondary outcomes, for example Change From Baseline in Peak Walking Time at Day 180, Change From Baseline in Peak Walking Time at Day 90, Change From Baseline in Claudication Onset Time at Day 180, Change From Baseline in Claudication Onset Time at Day 90, Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 180 and Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 90.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 164 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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