Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

NCT ID: NCT00415038

Last Updated: 2011-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2007-08-31

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rostafuroxin 50 micrograms capsules

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

Group Type: EXPERIMENTAL

Rostafuroxin

Intervention Type: 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

Rostafuroxin 150 micrograms capsules

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

Group Type: EXPERIMENTAL

Rostafuroxin

Intervention Type: DRUG

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 500 micrograms capsules

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

Group Type: EXPERIMENTAL

Rostafuroxin

Intervention Type: DRUG

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 1.5 mg capsules

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

Group Type: EXPERIMENTAL

Rostafuroxin

Intervention Type: DRUG

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 5 mg capsule

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

Group Type: EXPERIMENTAL

Rostafuroxin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Sigma Tau i.f.r. S.p.A.

Principal Investigators

Jan A Staessen, MD PhD

Role: STUDY_CHAIR

Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus Gasthuisberg

Hilde Celis, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Leuven Dept. of Molecular and cardiovascular Research, Laboratory of Hypertension

Kalina Kawecka-Jaszcz, MD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University Medical College Krakow - I Cardiac Department - Krakow (Poland)

Bogdan Wyrzykowski, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hypertension and Diabetology - Medical Academy - Gdansk (Poland)

Andrzej Tykarski, MD

Role: PRINCIPAL_INVESTIGATOR

Department of hypertension - School of Medicine - Poznan (Poland)

Miroslaw Dluzniewski, MD

Role: PRINCIPAL_INVESTIGATOR

Postgraduate Medical School - Department of cardiology - Warszawa (Poland)

Andrzey Januszewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Hypertension Warszawa (Poland)

Tomasz Grodzicki, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Gerontology - Jagiellonian University Medical College - Krakow (Poland)

Wieslawa Piwowarska, MD

Role: PRINCIPAL_INVESTIGATOR

Coronary Disease Department - Jagiellonian University medical College - Krakow (Poland)

Edoardo Casiglia, MD

Role: STUDY_DIRECTOR

IV Clinica Medica dell'Università di Padova, Dipartimento di Medicina Clinica e Sperimentale - Padova (Italy)

Giancarlo Basso, MD

Role: PRINCIPAL_INVESTIGATOR

U.O. Cardiologia - Ospedale Civile di Schio (Vicenza) Italy

Paolo Manunta, MD

Role: PRINCIPAL_INVESTIGATOR

Divisione di Nefrologia, Dialisi e Ipertensione - Ospedale S. Raffaele - Milano (Italy)

Nicola Glorioso, MD

Role: PRINCIPAL_INVESTIGATOR

Centro per L'ipertensione A.S.L. n° 1 - Sassari (Italy)

Gianni Bellomo, MD

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Medicina Interna, Nefrologia e dialisi - Ospedale San Giovanni Battista - Foligno (Perugia) Italy

Ezio Degli Esposti, MD

Role: PRINCIPAL_INVESTIGATOR

Unità di valutazione dell'efficacia clinica - Direzione Aziendale Ospedale S. Maria delle Croci - Ravenna (Italy)

Yuri Nikitin, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of internal Medicine, Siberian Branch of the Russian Academy of Medical Sciences - Novosibirsk (Russia)

Viktor Milyagin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Postgraduate Education Faculty Smolensk State medical Academy - Smolensk (Russia)

Sergey Nedogoda, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal and family Medicine - Volgograd (Russia)

James Barton, MD

Role: PRINCIPAL_INVESTIGATOR

Portiuncola Hospital Cardiac Research Department - Ballinasloe co Galway (Ireland)

Peter W De Leeuw, MD

Role: PRINCIPAL_INVESTIGATOR

Academisch Ziekenhuis Maastricht Afdeling Nefrologie - Mastricht (The Netherlands)

Marielle ME Krekels, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine/Nephrology Maaslandziekenhuis - Sittard (The Netherlands)

Rock Accetto, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical center, Hypertension Department - Ljubljana (Slovenia)

Fernando Hernandez-Menarguez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de la Salud de Vistalegre - La Flota, Murcia (Spain)

Jose a Aleman, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Salud Murcias San Andres - Murcia (Spain)

Carlos c Gomez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario - Santiago de Compostela (Spain)

Antonio Pose-Reino, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Conxo - Santiago de Compostela (Spain)

Jose M Pascual-Izuel, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sagunto - Sagunto (Valencia) - Spain

Josep Redon, MD

Role: PRINCIPAL_INVESTIGATOR

Hipertension Clinic, Hospital Clinico University of Valencia - Valencia (Spain)

Antonio Coca-Payeras, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico de Barcelona - Barcelona (Spain)

Jan Filipovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Derpartment of Internal Medicine 2, Faculty of Medicine - Pilsen (Czech Republic)

Miroslav Soucek, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine 2, St. Anne's Hospital, Faculty of Medicine - Brno (Czech Republic)

Michel Burnier, MD

Role: PRINCIPAL_INVESTIGATOR

Division de Nephrologie, Department de Medecine, Centre Hopitalier Universitaire Vaudois - Lausanne (Switzerland)

Locations

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

Leuven, , Belgium

Countries

Belgium

References

Staessen JA, Kuznetsova T, Acceto R, Bacchieri A, Brand E, Burnier M, Celis H, Citterio L, de Leeuw PW, Filipovsky J, Fournier A, Kawecka-Jaszcz K, Manunta P, Nikitin Y, O'Brien ET, Redon 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. doi: 10.2217/14622416.6.7.755.

Reference Type: BACKGROUND

PMID: 16207152 (View on PubMed)

Staessen JA, Thijs L, Stolarz-Skrzypek K, Bacchieri A, Barton J, Espositi ED, de Leeuw PW, Dluzniewski M, Glorioso N, Januszewicz A, Manunta P, Milyagin V, Nikitin Y, Soucek M, Lanzani C, Citterio L, Timio M, Tykarski A, Ferrari P, Valentini G, Kawecka-Jaszcz K, Bianchi G. Main results of the ouabain and adducin for Specific Intervention on Sodium in Hypertension Trial (OASIS-HT): a randomized placebo-controlled phase-2 dose-finding study of rostafuroxin. Trials. 2011 Jan 14;12:13. doi: 10.1186/1745-6215-12-13.

Reference Type: DERIVED

PMID: 21235787 (View on PubMed)

Other Identifiers

PST2238-DM-03-010

Identifier Type: -

Identifier Source: org_study_id