Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

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.

Conditions

• Essential Hypertension

Interventions

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.

  lead INDUSTRY

Principal Investigators

• Jan A Staessen, MD PhD · Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus Gasthuisberg

• Hilde Celis, MD · Catholic University of Leuven Dept. of Molecular and cardiovascular Research, Laboratory of Hypertension

• Kalina Kawecka-Jaszcz, MD · Jagiellonian University Medical College Krakow - I Cardiac Department - Krakow (Poland)

• Bogdan Wyrzykowski, MD · Department of Hypertension and Diabetology - Medical Academy - Gdansk (Poland)

• Andrzej Tykarski, MD · Department of hypertension - School of Medicine - Poznan (Poland)

• Miroslaw Dluzniewski, MD · Postgraduate Medical School - Department of cardiology - Warszawa (Poland)

• Andrzey Januszewicz, MD · Department of Internal Medicine and Hypertension Warszawa (Poland)

• Tomasz Grodzicki, MD · Department of Internal Medicine and Gerontology - Jagiellonian University Medical College - Krakow (Poland)

• Wieslawa Piwowarska, MD · Coronary Disease Department - Jagiellonian University medical College - Krakow (Poland)

• Edoardo Casiglia, MD · IV Clinica Medica dell'Università di Padova, Dipartimento di Medicina Clinica e Sperimentale - Padova (Italy)

• Giancarlo Basso, MD · U.O. Cardiologia - Ospedale Civile di Schio (Vicenza) Italy

• Paolo Manunta, MD · Divisione di Nefrologia, Dialisi e Ipertensione - Ospedale S. Raffaele - Milano (Italy)

• Nicola Glorioso, MD · Centro per L'ipertensione A.S.L. n° 1 - Sassari (Italy)

• Gianni Bellomo, MD · Dipartimento di Medicina Interna, Nefrologia e dialisi - Ospedale San Giovanni Battista - Foligno (Perugia) Italy

• Ezio Degli Esposti, MD · Unità di valutazione dell'efficacia clinica - Direzione Aziendale Ospedale S. Maria delle Croci - Ravenna (Italy)

• Yuri Nikitin, MD · Institute of internal Medicine, Siberian Branch of the Russian Academy of Medical Sciences - Novosibirsk (Russia)

• Viktor Milyagin, MD · Department of Internal Medicine, Postgraduate Education Faculty Smolensk State medical Academy - Smolensk (Russia)

• Sergey Nedogoda, MD · Department of Internal and family Medicine - Volgograd (Russia)

• James Barton, MD · Portiuncola Hospital Cardiac Research Department - Ballinasloe co Galway (Ireland)

• Peter W De Leeuw, MD · Academisch Ziekenhuis Maastricht Afdeling Nefrologie - Mastricht (The Netherlands)

• Marielle ME Krekels, MD · Department of Medicine/Nephrology Maaslandziekenhuis - Sittard (The Netherlands)

• Rock Accetto, MD · University Medical center, Hypertension Department - Ljubljana (Slovenia)

• Fernando Hernandez-Menarguez, MD · Centro de la Salud de Vistalegre - La Flota, Murcia (Spain)

• Jose a Aleman, MD · Centro de Salud Murcias San Andres - Murcia (Spain)

• Carlos c Gomez, MD · Hospital Clinico Universitario - Santiago de Compostela (Spain)

• Antonio Pose-Reino, MD · Hospital de Conxo - Santiago de Compostela (Spain)

• Jose M Pascual-Izuel, MD · Hospital de Sagunto - Sagunto (Valencia) - Spain

• Josep Redon, MD · Hipertension Clinic, Hospital Clinico University of Valencia - Valencia (Spain)

• Antonio Coca-Payeras, MD · Hospital Clinico de Barcelona - Barcelona (Spain)

• Jan Filipovsky, MD · Derpartment of Internal Medicine 2, Faculty of Medicine - Pilsen (Czech Republic)

• Miroslav Soucek, MD · Department of Internal Medicine 2, St. Anne's Hospital, Faculty of Medicine - Brno (Czech Republic)

• Michel Burnier, MD · Division de Nephrologie, Department de Medecine, Centre Hopitalier Universitaire Vaudois - Lausanne (Switzerland)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-02-28

Primary Completion

2007-04-30

Completion

2007-08-31

Countries

• Belgium

Study Locations