Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

NCT00415038 | Completed Phase 2 DMC

• 1 other identifier: PST2238-DM-03-010
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

hypertension; pharmacogenomic; adducin; ouabain; rostafuroxin

Outcome Measures

Primary Outcomes (1)

• Office Systolic Blood Pressure after 5 week of treatment

  5 weeks

Secondary Outcomes (5)

• Office Diastolic Blood Pressure

  5 weeks

• Proportion of normalised and responder patients (all visits)

  5 weeks

• 24 hours BP monitoring (through to peak ratio)

  5 weeks

• Effect on sub-populations, genetically selected

  5 weeks

• safety of the drug

  monitored during all the study

Study Arms (5)

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

Drug: Rostafuroxin

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

Drug: Rostafuroxin

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

Drug: Rostafuroxin

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

Drug: Rostafuroxin

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

Drug: Rostafuroxin

Interventions

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

Rostafuroxin 50 micrograms capsules

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Atrial fibrillation or left or right VBBB
• Left ventricular hypertrophy
• Significant renal or hepatic disease
• Obesity \> 30kg/m2
• Diabetes mellitus

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead

Study Sites (1)

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

Leuven, B-3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 16207152 BACKGROUND

• 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.

  PMID: 21235787 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

rostafuroxin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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)

  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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: February 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 17, 2011

Record last verified: 2011-06

Locations

BE (1)