drugset / Trial / NCT01320397

Antihypertensive Effect of Rostafuroxin Compared With Losartan in Hypertensive Patients Bearing Specified Gene Mutations

NCT01320397

Phase 2 Unknown 240 enrolled RostaQuo S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients carrying at least one of the pre-specified gene mutations. In previous studies has been demonstrated that these mutations are able to induce specific alterations inducing an increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of these alterations, and so directly reverse the increase in blood pressure.

Timeline

Start
2011-05
Primary completion
2012-07
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Losartan Other / unclassified 50 mg Oral
Subject Rostafuroxin Small molecule 6 ug Oral
Subject Rostafuroxin Small molecule 50 ug Oral
Subject Rostafuroxin Small molecule 500 ug Oral