Back to resultsEfficacy of Rostafuroxin in the Treatment of Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Rostafuroxin
Rostafuroxin
Rostafuroxin
Rostafuroxin
Rostafuroxin
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring hypertension, pharmacogenomic, adducin, ouabain, rostafuroxin
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
Sites / Locations
- Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Rostafuroxin 50 micrograms capsules
Rostafuroxin 150 micrograms capsules
Rostafuroxin 500 micrograms capsules
Rostafuroxin 1.5 mg capsules
Rostafuroxin 5 mg capsule
Arm Description
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
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
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
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
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
Outcomes
Primary Outcome Measures
Office Systolic Blood Pressure after 5 week of treatment
Secondary Outcome Measures
Office Diastolic Blood Pressure
Proportion of normalised and responder patients (all visits)
24 hours BP monitoring (through to peak ratio)
Effect on sub-populations, genetically selected
safety of the drug
Full Information
NCT ID
NCT00415038
First Posted
December 21, 2006
Last Updated
June 16, 2011
Sponsor
sigma-tau i.f.r. S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT00415038
Brief Title
Efficacy of Rostafuroxin in the Treatment of Essential Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
sigma-tau i.f.r. S.p.A.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
hypertension, pharmacogenomic, adducin, ouabain, rostafuroxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
438 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rostafuroxin 50 micrograms capsules
Arm Type
Experimental
Arm Description
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
Arm Title
Rostafuroxin 150 micrograms capsules
Arm Type
Experimental
Arm Description
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
Arm Title
Rostafuroxin 500 micrograms capsules
Arm Type
Experimental
Arm Description
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
Arm Title
Rostafuroxin 1.5 mg capsules
Arm Type
Experimental
Arm Description
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
Arm Title
Rostafuroxin 5 mg capsule
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rostafuroxin
Intervention Description
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
Intervention Name(s)
Rostafuroxin
Intervention Description
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
Intervention Name(s)
Rostafuroxin
Intervention Description
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
Intervention Name(s)
Rostafuroxin
Intervention Description
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
Intervention Name(s)
Rostafuroxin
Intervention Description
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
Primary Outcome Measure Information:
Title
Office Systolic Blood Pressure after 5 week of treatment
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Office Diastolic Blood Pressure
Time Frame
5 weeks
Title
Proportion of normalised and responder patients (all visits)
Time Frame
5 weeks
Title
24 hours BP monitoring (through to peak ratio)
Time Frame
5 weeks
Title
Effect on sub-populations, genetically selected
Time Frame
5 weeks
Title
safety of the drug
Time Frame
monitored during all the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Staessen, MD PhD
Organizational Affiliation
Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus Gasthuisberg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hilde Celis, MD
Organizational Affiliation
Catholic University of Leuven Dept. of Molecular and cardiovascular Research, Laboratory of Hypertension
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kalina Kawecka-Jaszcz, MD
Organizational Affiliation
Jagiellonian University Medical College Krakow - I Cardiac Department - Krakow (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bogdan Wyrzykowski, MD
Organizational Affiliation
Department of Hypertension and Diabetology - Medical Academy - Gdansk (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrzej Tykarski, MD
Organizational Affiliation
Department of hypertension - School of Medicine - Poznan (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miroslaw Dluzniewski, MD
Organizational Affiliation
Postgraduate Medical School - Department of cardiology - Warszawa (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrzey Januszewicz, MD
Organizational Affiliation
Department of Internal Medicine and Hypertension Warszawa (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomasz Grodzicki, MD
Organizational Affiliation
Department of Internal Medicine and Gerontology - Jagiellonian University Medical College - Krakow (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wieslawa Piwowarska, MD
Organizational Affiliation
Coronary Disease Department - Jagiellonian University medical College - Krakow (Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edoardo Casiglia, MD
Organizational Affiliation
IV Clinica Medica dell'Università di Padova, Dipartimento di Medicina Clinica e Sperimentale - Padova (Italy)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giancarlo Basso, MD
Organizational Affiliation
U.O. Cardiologia - Ospedale Civile di Schio (Vicenza) Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Manunta, MD
Organizational Affiliation
Divisione di Nefrologia, Dialisi e Ipertensione - Ospedale S. Raffaele - Milano (Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicola Glorioso, MD
Organizational Affiliation
Centro per L'ipertensione A.S.L. n° 1 - Sassari (Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gianni Bellomo, MD
Organizational Affiliation
Dipartimento di Medicina Interna, Nefrologia e dialisi - Ospedale San Giovanni Battista - Foligno (Perugia) Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ezio Degli Esposti, MD
Organizational Affiliation
Unità di valutazione dell'efficacia clinica - Direzione Aziendale Ospedale S. Maria delle Croci - Ravenna (Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuri Nikitin, MD
Organizational Affiliation
Institute of internal Medicine, Siberian Branch of the Russian Academy of Medical Sciences - Novosibirsk (Russia)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Viktor Milyagin, MD
Organizational Affiliation
Department of Internal Medicine, Postgraduate Education Faculty Smolensk State medical Academy - Smolensk (Russia)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergey Nedogoda, MD
Organizational Affiliation
Department of Internal and family Medicine - Volgograd (Russia)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Barton, MD
Organizational Affiliation
Portiuncola Hospital Cardiac Research Department - Ballinasloe co Galway (Ireland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter W De Leeuw, MD
Organizational Affiliation
Academisch Ziekenhuis Maastricht Afdeling Nefrologie - Mastricht (The Netherlands)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marielle ME Krekels, MD
Organizational Affiliation
Department of Medicine/Nephrology Maaslandziekenhuis - Sittard (The Netherlands)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rock Accetto, MD
Organizational Affiliation
University Medical center, Hypertension Department - Ljubljana (Slovenia)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Hernandez-Menarguez, MD
Organizational Affiliation
Centro de la Salud de Vistalegre - La Flota, Murcia (Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose a Aleman, MD
Organizational Affiliation
Centro de Salud Murcias San Andres - Murcia (Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos c Gomez, MD
Organizational Affiliation
Hospital Clinico Universitario - Santiago de Compostela (Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Pose-Reino, MD
Organizational Affiliation
Hospital de Conxo - Santiago de Compostela (Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose M Pascual-Izuel, MD
Organizational Affiliation
Hospital de Sagunto - Sagunto (Valencia) - Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josep Redon, MD
Organizational Affiliation
Hipertension Clinic, Hospital Clinico University of Valencia - Valencia (Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Coca-Payeras, MD
Organizational Affiliation
Hospital Clinico de Barcelona - Barcelona (Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Filipovsky, MD
Organizational Affiliation
Derpartment of Internal Medicine 2, Faculty of Medicine - Pilsen (Czech Republic)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miroslav Soucek, MD
Organizational Affiliation
Department of Internal Medicine 2, St. Anne's Hospital, Faculty of Medicine - Brno (Czech Republic)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Burnier, MD
Organizational Affiliation
Division de Nephrologie, Department de Medecine, Centre Hopitalier Universitaire Vaudois - Lausanne (Switzerland)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
16207152
Citation
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.
Results Reference
background
PubMed Identifier
21235787
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of Rostafuroxin in the Treatment of Essential Hypertension
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