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Completed

NCT Number: NCT00415038

Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg

Leuven, B-3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rostafuroxin

Drug

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

Primary outcomes

  1. Office Systolic Blood Pressure after 5 week of treatment

    Time frame: 5 weeks

Secondary outcomes

  1. Office Diastolic Blood Pressure

    Time frame: 5 weeks

  2. Proportion of normalised and responder patients (all visits)

    Time frame: 5 weeks

  3. 24 hours BP monitoring (through to peak ratio)

    Time frame: 5 weeks

  4. Effect on sub-populations, genetically selected

    Time frame: 5 weeks

  5. safety of the drug

    Time frame: monitored during all the study

Sponsors and collaborators

Lead sponsor

sigma-tau i.f.r. S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 22, 2006
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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