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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

Completed Phase 3 Last updated 22 December 2022
What this trial tests

Phase 3 trial testing Losartan in Marfan Syndrome in 22 participants. Completed in 26 November 2014.

Timeline
1 November 2009
Primary endpoint
26 November 2014
26 November 2014

Quick facts

Lead sponsorUniversity Hospital, Ghent
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment22
Start date1 November 2009
Primary completion26 November 2014
Estimated completion26 November 2014
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Ghent

Who can join

10 and older, any sex, with Marfan Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting the TGFβ signalling pathway in disease.
    Akhurst RJ, Hata A. · · 2012 · cited 1225× · PMID 23000686 · DOI 10.1038/nrd3810
  2. Medical treatment of aortic aneurysms in Marfan syndrome and other heritable conditions.
    Attenhofer Jost CH, Greutmann M, Connolly HM, Weber R, et al · · 2014 · cited 24× · PMID 24527681 · DOI 10.2174/1573403x1002140506124902
  3. Preventing the aortic complications of Marfan syndrome: a case-example of translational genomic medicine.
    Li-Wan-Po A, Loeys B, Farndon P, Latham D, et al · · 2011 · cited 4× · PMID 21276043 · DOI 10.1111/j.1365-2125.2011.03929.x

Verify or expand the search:

Other trials of Losartan

Trials testing the same drug.

Other recruiting trials for Marfan Syndrome

Currently open trials in the same condition.

Other University Hospital, Ghent trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00782327.

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