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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rostafuroxin 50 micrograms capsules | Experimental | 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 150 micrograms capsules | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rostafuroxin | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Office Systolic Blood Pressure after 5 week of treatment | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Office Diastolic Blood Pressure | 5 weeks | |
| Proportion of normalised and responder patients (all visits) | 5 weeks | |
| 24 hours BP monitoring (through to peak ratio) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan A Staessen, MD PhD | Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus Gasthuisberg | Study Chair |
| 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) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg | Leuven | B-3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16207152 | Background | 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. | |
| 21235787 |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C106263 | rostafuroxin |
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| Rostafuroxin | 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 | 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 | 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 | 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 |
|
| 5 weeks |
| Effect on sub-populations, genetically selected | 5 weeks |
| safety of the drug | monitored during all the study |
| Principal Investigator |
| Wieslawa Piwowarska, MD | Coronary Disease Department - Jagiellonian University medical College - Krakow (Poland) | Principal Investigator |
| Edoardo Casiglia, MD | IV Clinica Medica dell'Università di Padova, Dipartimento di Medicina Clinica e Sperimentale - Padova (Italy) | Study Director |
| 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) | Principal Investigator |
| 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. |