Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)

What Was Tested

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

Carnitine allows muscles to function properly.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Investigational drug.

The registry classes the interventions as drug.

Who Took Part

69 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Ambulatory outpatient who are able to exercise. Intermittent claudication due to peripheral artery disease. Willingness to participate in a monitored exercise training program.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: pain at rest, ischemic ulcerations, gangrene of the lower extremity; peripheral artery disease of a non-atherosclerotic nature; current participation in an exercise training program or previous participtation in a monitored exercise training program within 6 months of the screening visit.

How the Study Was Run

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

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2006-04 with completion listed for 2008-03.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Peak walking time (time frame: 6 months).

It also tracked 1 secondary outcome, for example Claudication onset time, activity level and quality of life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 69 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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