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

NCT01320397 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-03-23

No results posted yet for this study

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.

Conditions

  • Essential Hypertension

Interventions

DRUG

Rostafuroxin

6 microgram capsules

DRUG

Rostafuroxin

50 micrograms capsules

DRUG

Rostafuroxin

500 micrograms capsules

DRUG

Losartan

Losartan 50 mg once a day

Sponsors & Collaborators

  • RostaQuo S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jan A Staessen, MD PhD · Laboratory of Hypertension, University of Leuven, B-3000 Leuven - BELGIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Ireland
  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320397 on ClinicalTrials.gov