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A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
Plain-language guide to NCT00809497: phase 3 randomized trial of L-Carnitine, 239 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00809497
- Phase
- phase 3
- Status
- completed
- Start
- 2008-05
- Completion (planned or actual)
- 2009-09
- Participants
- 239 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Peripheral Arterial Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test L-Carnitine.
The registry classes the interventions as drug.
More on the Plan
This is a randomized, multi-centre, double-blind and placebo controlled clinical study.
Who Took Part
The registry lists 239 actual participants took part.
It was open to people of any sex aged from 40 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: At the last visit during the wash-out period, the ABI at rest must be ,0.9.
The full record lists 2 inclusion and 16 exclusion criteria; among the exclusions: with rest pain, ulceration, and/or gangrene; PAD of a non-atherosclerotic nature; except pad, any concomitant disease that can limit patients' performance in the treadmill exercise.
How the Study Was Run
Design: randomized, parallel-group and double-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.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.
Those kept unaware of assignments: participant and investigator.
It started in 2008-05 with completion listed for 2009-09.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): To compare the difference between pre-and post-the treatment of each group (time frame: 4 months).
It also tracked 1 secondary outcome, for example Statistically describe the variance of ABI, CT and other indexes at the end of 4th month.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of L-Carnitine in 239 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.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.