Efficacy of Rostafuroxin in the Treatment of Essential Hypertension
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ClinicalTrials.gov Identifier: NCT00415038 |
Recruitment Status :
Completed
First Posted : December 22, 2006
Last Update Posted : June 17, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Hypertension | Drug: Rostafuroxin | Phase 2 |
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 |

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 |
- Office Systolic Blood Pressure after 5 week of treatment [ Time Frame: 5 weeks ]
- Office Diastolic Blood Pressure [ Time Frame: 5 weeks ]
- Proportion of normalised and responder patients (all visits) [ Time Frame: 5 weeks ]
- 24 hours BP monitoring (through to peak ratio) [ Time Frame: 5 weeks ]
- Effect on sub-populations, genetically selected [ Time Frame: 5 weeks ]
- safety of the drug [ Time Frame: monitored during all the study ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415038
Belgium | |
Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg | |
Leuven, Belgium, B-3000 |
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) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Giovanni Valentini, Sigma Tau i.f.r. S.p.A. |
ClinicalTrials.gov Identifier: | NCT00415038 |
Other Study ID Numbers: |
PST2238-DM-03-010 |
First Posted: | December 22, 2006 Key Record Dates |
Last Update Posted: | June 17, 2011 |
Last Verified: | June 2011 |
hypertension pharmacogenomic adducin ouabain rostafuroxin |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases |