Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Rostafuroxin

• Registration Number: NCT00415038
• Lead Sponsor: sigma-tau i.f.r. S.p.A.

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Primary Completion: 2007-04
• Study Completion: 2007-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rostafuroxin 150 micrograms capsules	Rostafuroxin	5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
Rostafuroxin 5 mg capsule	Rostafuroxin	5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
Rostafuroxin 50 micrograms capsules	Rostafuroxin	5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
Rostafuroxin 500 micrograms capsules	Rostafuroxin	5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
Rostafuroxin 1.5 mg capsules	Rostafuroxin	5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design

Primary Outcome Measures

Name	Time	Method
Office Systolic Blood Pressure after 5 week of treatment	5 weeks

Secondary Outcome Measures

Name	Time	Method
safety of the drug	monitored during all the study
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

Trial Locations

Locations (1)

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