Essential HypertensionPhase 2NCT00415038
Efficacy of Rostafuroxin in the Treatment of Essential Hypertension
A Phase 2 study testing Rostafuroxin in people with Essential Hypertension, run by sigma-tau i.f.r. S.p.A. at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Rostafuroxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2005to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Atrial fibrillation or left or right VBBB
- Left ventricular hypertrophy
- Significant renal or hepatic disease
- Obesity > 30kg/m2
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Catholic University of Leuven - Laboratory of Hypertension, Dept. of Molecular and Cardiov. Research - Campus Gasthuisberg
Leuven, B-3000
About this study
Official title: A Double Blind, Dose Range, Placebo Controlled Study of the Effects of Rostafuroxin vs Placebo in Patients With Stable, Uncomplicated, Essential Hypertension.
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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Rostafuroxin
- Keywords
- hypertension, pharmacogenomic, adducin, ouabain, rostafuroxin
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RostafuroxinDrug
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
RostafuroxinDrug
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
RostafuroxinDrug
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
RostafuroxinDrug
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
RostafuroxinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Rostafuroxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office Systolic Blood Pressure after 5 week of treatment
Measured: 5 weeks
Secondary outcomes (5)
Office Diastolic Blood Pressure
Measured: 5 weeks
Proportion of normalised and responder patients (all visits)
Measured: 5 weeks
24 hours BP monitoring (through to peak ratio)
Measured: 5 weeks
Effect on sub-populations, genetically selected
Measured: 5 weeks
safety of the drug
Measured: monitored during all the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startFeb 2005
- Primary completionApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan A Staessen, MD PhD, Study chair, Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus GasthuisbergHilde Celis, MD, Principal investigator, Catholic University of Leuven Dept. of Molecular and cardiovascular Research, Laboratory of HypertensionKalina Kawecka-Jaszcz, MD, Principal investigator, Jagiellonian University Medical College Krakow - I Cardiac Department - Krakow (Poland)Bogdan Wyrzykowski, MD, Principal investigator, Department of Hypertension and Diabetology - Medical Academy - Gdansk (Poland)Andrzej Tykarski, MD, Principal investigator, Department of hypertension - School of Medicine - Poznan (Poland)Miroslaw Dluzniewski, MD, Principal investigator, Postgraduate Medical School - Department of cardiology - Warszawa (Poland)Andrzey Januszewicz, MD, Principal investigator, Department of Internal Medicine and Hypertension Warszawa (Poland)Tomasz Grodzicki, MD, Principal investigator, Department of Internal Medicine and Gerontology - Jagiellonian University Medical College - Krakow (Poland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415038
- Sponsor's protocol ID
- PST2238-DM-03-010
- Status last verified
- Jun 2011
- First submitted
- 21 Dec 2006
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16207152Staessen 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.
PubMed 21235787
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Dose Range, Placebo Controlled Study of the Effects of Rostafuroxin vs Placebo in Patients With Stable, Uncomplicated, Essential Hypertension.
- ClinicalTrials.gov ID
- NCT00415038
- Acronym / sponsor ID
- PST2238-DM-03-010
- Conditions
- Essential Hypertension
- Keywords
- hypertension, pharmacogenomic, adducin, ouabain, rostafuroxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rostafuroxin 50 micrograms capsules | Experimental | Drug: Rostafuroxin5 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 | Drug: Rostafuroxin5 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 | Drug: Rostafuroxin5 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 | Drug: Rostafuroxin5 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 | Drug: Rostafuroxin5 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 |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Atrial fibrillation or left or right VBBB
- Left ventricular hypertrophy
- Significant renal or hepatic disease
- Obesity > 30kg/m2
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rostafuroxin1 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 | Drug | Rostafuroxin 50 micrograms capsules |
| Rostafuroxin1 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 | Drug | Rostafuroxin 150 micrograms capsules |
| Rostafuroxin1 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 | Drug | Rostafuroxin 500 micrograms capsules |
| Rostafuroxin1 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 | Drug | Rostafuroxin 1.5 mg capsules |
| Rostafuroxin1 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 | Drug | Rostafuroxin 5 mg capsule |
Primary outcome
Office Systolic Blood Pressure after 5 week of treatment
Time frame: 5 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
- Background: PubMed 16207152Staessen 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.
- Derived from this study: PubMed 21235787Staessen 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.
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan A Staessen, MD PhD study chair
Catholic University of Leuven, Laboratory of Hypertension Dept. of Molecular and cardiovascular Resesrach - Campus Gasthuisberg
Hilde Celis, MD principal investigator
Catholic University of Leuven Dept. of Molecular and cardiovascular Research, Laboratory of Hypertension
Kalina Kawecka-Jaszcz, MD principal investigator
Jagiellonian University Medical College Krakow - I Cardiac Department - Krakow (Poland)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rostafuroxin in people with Essential Hypertension, run by sigma-tau i.f.r. S.p.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office Systolic Blood Pressure after 5 week of treatment (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00415038, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.