Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

• Sponsor: sigma-tau i.f.r. S.p.A.
• Information provided by: sigma-tau i.f.r. S.p.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Drug: Rostafuroxin	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	438 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Double Blind, Dose Range, Placebo Controlled Study of the Effects of Rostafuroxin vs Placebo in Patients With Stable, Uncomplicated, Essential Hypertension.
Study Start Date :	February 2005
Actual Primary Completion Date :	April 2007
Actual Study Completion Date :	August 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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
Experimental: 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	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
Experimental: 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	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
Experimental: 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	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
Experimental: 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	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

Outcome Measures

Primary Outcome Measures :

1. Office Systolic Blood Pressure after 5 week of treatment [ Time Frame: 5 weeks ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Locations

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Belgium
Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg
Leuven, Belgium, B-3000

Sponsors and Collaborators

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

Investigators

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Study Chair:	Jan A Staessen, MD PhD	Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus Gasthuisberg
Principal Investigator:	Hilde Celis, MD	Catholic University of Leuven Dept. of Molecular and cardiovascular Research, Laboratory of Hypertension
Principal Investigator:	Kalina Kawecka-Jaszcz, MD	Jagiellonian University Medical College Krakow - I Cardiac Department - Krakow (Poland)
Principal Investigator:	Bogdan Wyrzykowski, MD	Department of Hypertension and Diabetology - Medical Academy - Gdansk (Poland)
Principal Investigator:	Andrzej Tykarski, MD	Department of hypertension - School of Medicine - Poznan (Poland)
Principal Investigator:	Miroslaw Dluzniewski, MD	Postgraduate Medical School - Department of cardiology - Warszawa (Poland)
Principal Investigator:	Andrzey Januszewicz, MD	Department of Internal Medicine and Hypertension Warszawa (Poland)
Principal Investigator:	Tomasz Grodzicki, MD	Department of Internal Medicine and Gerontology - Jagiellonian University Medical College - Krakow (Poland)
Principal Investigator:	Wieslawa Piwowarska, MD	Coronary Disease Department - Jagiellonian University medical College - Krakow (Poland)
Study Director:	Edoardo Casiglia, MD	IV Clinica Medica dell'Università di Padova, Dipartimento di Medicina Clinica e Sperimentale - Padova (Italy)
Principal Investigator:	Giancarlo Basso, MD	U.O. Cardiologia - Ospedale Civile di Schio (Vicenza) Italy
Principal Investigator:	Paolo Manunta, MD	Divisione di Nefrologia, Dialisi e Ipertensione - Ospedale S. Raffaele - Milano (Italy)
Principal Investigator:	Nicola Glorioso, MD	Centro per L'ipertensione A.S.L. n° 1 - Sassari (Italy)
Principal Investigator:	Gianni Bellomo, MD	Dipartimento di Medicina Interna, Nefrologia e dialisi - Ospedale San Giovanni Battista - Foligno (Perugia) Italy
Principal Investigator:	Ezio Degli Esposti, MD	Unità di valutazione dell'efficacia clinica - Direzione Aziendale Ospedale S. Maria delle Croci - Ravenna (Italy)
Principal Investigator:	Yuri Nikitin, MD	Institute of internal Medicine, Siberian Branch of the Russian Academy of Medical Sciences - Novosibirsk (Russia)
Principal Investigator:	Viktor Milyagin, MD	Department of Internal Medicine, Postgraduate Education Faculty Smolensk State medical Academy - Smolensk (Russia)
Principal Investigator:	Sergey Nedogoda, MD	Department of Internal and family Medicine - Volgograd (Russia)
Principal Investigator:	James Barton, MD	Portiuncola Hospital Cardiac Research Department - Ballinasloe co Galway (Ireland)
Principal Investigator:	Peter W De Leeuw, MD	Academisch Ziekenhuis Maastricht Afdeling Nefrologie - Mastricht (The Netherlands)
Principal Investigator:	Marielle ME Krekels, MD	Department of Medicine/Nephrology Maaslandziekenhuis - Sittard (The Netherlands)
Principal Investigator:	Rock Accetto, MD	University Medical center, Hypertension Department - Ljubljana (Slovenia)
Principal Investigator:	Fernando Hernandez-Menarguez, MD	Centro de la Salud de Vistalegre - La Flota, Murcia (Spain)
Principal Investigator:	Jose a Aleman, MD	Centro de Salud Murcias San Andres - Murcia (Spain)
Principal Investigator:	Carlos c Gomez, MD	Hospital Clinico Universitario - Santiago de Compostela (Spain)
Principal Investigator:	Antonio Pose-Reino, MD	Hospital de Conxo - Santiago de Compostela (Spain)
Principal Investigator:	Jose M Pascual-Izuel, MD	Hospital de Sagunto - Sagunto (Valencia) - Spain
Principal Investigator:	Josep Redon, MD	Hipertension Clinic, Hospital Clinico University of Valencia - Valencia (Spain)
Principal Investigator:	Antonio Coca-Payeras, MD	Hospital Clinico de Barcelona - Barcelona (Spain)
Principal Investigator:	Jan Filipovsky, MD	Derpartment of Internal Medicine 2, Faculty of Medicine - Pilsen (Czech Republic)
Principal Investigator:	Miroslav Soucek, MD	Department of Internal Medicine 2, St. Anne's Hospital, Faculty of Medicine - Brno (Czech Republic)
Principal Investigator:	Michel Burnier, MD	Division de Nephrologie, Department de Medecine, Centre Hopitalier Universitaire Vaudois - Lausanne (Switzerland)

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Staessen JA, Thijs L, Stolarz-Skrzypek K, Bacchieri A, Barton J, Espositi ED, de Leeuw PW, Dłużniewski M, Glorioso N, Januszewicz A, Manunta P, Milyagin V, Nikitin Y, Souček 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.

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Responsible Party:	Giovanni Valentini, Sigma Tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:	NCT00415038 History of Changes
Other Study ID Numbers:	PST2238-DM-03-010
First Posted:	December 22, 2006
Last Update Posted:	June 17, 2011
Last Verified:	June 2011

Keywords provided by sigma-tau i.f.r. S.p.A.:

hypertension; pharmacogenomic; adducin; ouabain; rostafuroxin

Additional relevant MeSH terms:

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Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases