Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

A Double Blind, Dose Range, Placebo Controlled Study of the Effects of Rostafuroxin vs Placebo in Patients With Stable, Uncomplicated, Essential Hypertension.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00415038

Enrollment

438

Registered

2006-12-22

Start date

2005-02-28

Completion date

2007-08-31

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

hypertension, pharmacogenomic, adducin, ouabain, rostafuroxin

Brief summary

The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of essential hypertension and to determine the best effective dose to be administered in the general hypertensive population and in a subset of this population in which genetic patterns could be involved in the etiology of essential hypertension.

Detailed description

Elevated arterial pressure is probably the most important public health problem. about 30% of the world adult population are affected by hypertension in industrialised countries. Development of a pharmacogenomic approach to the therapy of primary hypertension give new opportunities for the treatment of hypertension. This approach consists in the identification of the genetic-molecular mechanisms responsible for hypertension in a given subset of patients, and in the development of drugs able to interfere with such mechanisms, thus leading to very selective therapeutic interventions with enhanced efficacy and reduced side effects.

Interventions

DRUGRostafuroxin

1 capusle of 50 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 59 Years

Healthy volunteers

Inclusion criteria

* Patients with grade 1 or 2 of essential hypertension * Less than 3 risk factors (age \> 55 if male, smoking, dyslipidemia, family history of CV disease occurring before 55 years in men and 65 in women * Naive patients or currently on monotherapy or one combination tablet * SBP between 140 and 169 mmHg

Exclusion criteria

* Atrial fibrillation or left or right VBBB * Left ventricular hypertrophy * Significant renal or hepatic disease * Obesity \> 30kg/m2 * Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Office Systolic Blood Pressure after 5 week of treatment	5 weeks

Secondary

Measure	Time frame
Office Diastolic Blood Pressure	5 weeks
Proportion of normalised and responder patients (all visits)	5 weeks
24 hours BP monitoring (through to peak ratio)	5 weeks
Effect on sub-populations, genetically selected	5 weeks
safety of the drug	monitored during all the study

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026