drugset / Trial / NCT00388128
Caffeine and Intermittent Claudication
Phase 3
Completed
80 enrolled
University of Aarhus
Central Jutland Regional Hospital · collabHerning Hospital · collab
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed, balance, cognitive function, health related quality of life (SF-36).
Timeline
- Start
- 2006-09
- Primary completion
- 2009-05
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Caffeine | Small molecule | 6 mg/kg | Oral |