Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415038
• Other study ID #: PST2238-DM-03-010
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2006
• Last updated: June 16, 2011
• Start date: February 2005
• Est. completion date: August 2007

Study information

• Verified date: June 2011
• Source: sigma-tau i.f.r. S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Algemene Farmaceutische Inspectie Dienst Onderzoek en OntwikkelingPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSwitzerland: SwissmedicCzech Republic: State Institute of drug controlItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthRussia: Ministry of Health of the Russian FederationSlovenia: Agency for Medicinal Products - Ministry of HealthIreland: Irish Medicines BoardNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: August 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 59 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Rostafuroxin
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
• Rostafuroxin
1 capusle of 150 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
• Rostafuroxin
1 capusle of 500 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
• Rostafuroxin
1 capusle of 1.5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
• Rostafuroxin
1 capusle of 5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin

Locations

Country	Name	City	State
Belgium	Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
sigma-tau i.f.r. S.p.A.

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Staessen JA, Kuznetsova T, Acceto R, Bacchieri A, Brand E, Burnier M, Celis H, Citterio L, de Leeuw PW, Filipovský J, Fournier A, Kawecka-Jaszcz K, Manunta P, Nikitin Y, O'Brien ET, Redón J, Thijs L, Ferrari P, Valentini G, Bianchi G. OASIS-HT: design of a pharmacogenomic dose-finding study. Pharmacogenomics. 2005 Oct;6(7):755-75. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Office Systolic Blood Pressure after 5 week of treatment		5 weeks	No
Secondary	Office Diastolic Blood Pressure		5 weeks	No
Secondary	Proportion of normalised and responder patients (all visits)		5 weeks	No
Secondary	24 hours BP monitoring (through to peak ratio)		5 weeks	No
Secondary	Effect on sub-populations, genetically selected		5 weeks	No
Secondary	safety of the drug		monitored during all the study	No