drugset / Trial / NCT00782327
Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers
Phase 3
Completed
22 enrolled
University Hospital, Ghent
Agentschap voor Innovatie door Wetenschap en Technologie · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration. Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg
Timeline
- Start
- 2009-11-01
- Primary completion
- 2014-11-26
- Completion
- 2014-11-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Losartan | Other / unclassified | 50 mg | — |
| Subject | Losartan | Other / unclassified | 100 mg | — |