Antihypertensive Effect of Rostafuroxin Compared With Losartan in Hypertensive Patients Bearing Specified Gene Mutations
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by RostaQuo S.p.A..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
RostaQuo S.p.A.
Information provided by:
RostaQuo S.p.A.
ClinicalTrials.gov Identifier:
NCT01320397
First received: March 16, 2011
Last updated: March 22, 2011
Last verified: March 2011
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Purpose
The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients carrying at least one of the pre-specified gene mutations. In previous studies has been demonstrated that these mutations are able to induce specific alterations inducing an increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of these alterations, and so directly reverse the increase in blood pressure.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: Rostafuroxin Drug: Losartan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan, Assessed by Office and Ambulatory Blood Pressure Monitoring in a Hypertensive Population Selected According to a Specific Genetic Profile |
Resource links provided by NLM:
Further study details as provided by RostaQuo S.p.A.:
Primary Outcome Measures:
- Systolic Blood Pressure [ Time Frame: Week 9 of treatment versus baseline ] [ Designated as safety issue: No ]
Automated sitting and standing SBP and DBP will be recorded by physician at baseline (two visits) and at week 2, 5 and 9 of treatement.
sitting: after the patient has rested for at least 10 minutes in a quiet room. There are five consecutive sitting BP readings with a 30 to 60 seconds interval between the readings; the mean of the last three sitting BP will be used.
The standing BP is measured twice immediately after the patient assumed the standing position.
Secondary Outcome Measures:
- Diastolic blood pressure [ Time Frame: Baseline (two visits) and then at week 2, 5 and 9 of treatment ] [ Designated as safety issue: No ]Diastolic blood pressure measurements will be performed at the same times of the systolic blood pressure measurements, as described above.
- Trough-to-peak ratio on Systolic Blood Pressure [ Time Frame: Throughout 24 hours ABPM ] [ Designated as safety issue: No ]Ambulatory Blood Pressure Monitoring (ABPM)will be performed throuhgout 24 hours at baseline and at week 9 of treatement. Readings will be Centralized. The Core Laboratory will be in charge for data interpretation.
- Number of participants with adverse events [ Time Frame: throughout all the study period and follow-up (30 days) ] [ Designated as safety issue: No ]All the Adverse Events will be recorded and followed-up till their resolution. Number of Adverse Events in each group treatment will be computed, including single event frequencies and number of patients with adverse events. AEs will be collected on spontaneous reporting by patients and a number of standard safety procedure: i.e. recording of ECGs, standard blood chemistry and haematology, performed before, during and at the end of the treatment period.
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rostafuroxin 6 micrograms capsules
1 capsule of ROSTAFUROXIN (6 micrograms) once a day before breakfast.
|
Drug: Rostafuroxin
6 microgram capsules
Other Name: PST2238
|
|
Experimental: Rostafuroxin 50 micrograms capsules
1 capsule of ROSTAFUROXIN (50 micrograms) once a day before breakfast.
|
Drug: Rostafuroxin
50 micrograms capsules
Other Name: PST2238
|
|
Experimental: Rostafuroxin 500 micrograms
1 capsule of ROSTAFUROXIN (500 micrograms) once a day before breakfast.
|
Drug: Rostafuroxin
500 micrograms capsules
Other Name: PST2238
|
|
Experimental: Losartan 50 mg encapsulated
1 capsule containing one cpr of Losartan 50 mg once a day before breakfast.
|
Drug: Losartan
Losartan 50 mg once a day
Other Name: Losaprex
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signature of a written informed consent, included informed consent on genotype analysis.
- Naive hypertensive patient (new diagnosed patient, never treated before).
- Documented mild to moderate arterial hypertension: SBP comprised between 140 and 169 mmHg and DBP between 85 and 100 mmHg;
- Presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in the protocol.
Exclusion Criteria:
- Known causes of secondary or severe or malignant hypertension;
- Significant renal or hepatic disease;
- Cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months;
- Atrial Fibrillation or Complete Ventricle Bundle Branch Block;
- First degree AV-block exceeding 240 msec;
- Electrocardiographic evidence of left ventricular hypertrophy;
- Pregnant or nursing women or women of childbearing potential not taking anti-contraceptive medication or not utilizing a double contraceptive method;
- Concomitant therapy with medications that may affect blood pressure;
- Diabetes mellitus (fasting plasma glucose > 125 mg/dl);
- Statins treatment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320397
Contacts
| Contact: Giovanni Valentini, MD | +39 06 91393916 | giovanni.valentini@sigma-tau.it |
| Contact: Vittorio Dainese, Biologist | +39 06 913934285 | vittorio.dainese@sigma-tau.it |
Locations
| Ireland | |
| Portiuncula Hospital | |
| Ballinasloe, Galway, Ireland | |
| James Connolly memorial Hospital | |
| Dublin, Ireland, 15 | |
| Clinical research centre, Beaumont Hospital | |
| Dublin, Ireland, 9 | |
| Italy | |
| Unità Operativa di Nefrologia e Dialisi, Ospedale "S. Maria della Scaletta" | |
| Imola, Bologna, Italy, 40026 | |
| Ospedale "Santa Maria" | |
| Borgo Val di Taro, Parma, Italy, 43023 | |
| Divisione di Cardiologia e UTIC Ospedale "Marianna Giannuzzi" | |
| Manduria, Taranto, Italy, 74024 | |
| Reparto di Emodialisi, Ospedale dell'Angelo | |
| Mestre, Venezia, Italy, 30174 | |
| U.O. di Nefrologia e Dialisi, Ospedale San Donato | |
| Arezzo, Italy, 52100 | |
| U.O Nefrologia, Dialisi e Ipertensione, Policlinico S. Orsola-Malpighi | |
| Bologna, Italy, 40138 | |
| Cattedra di Medicina Interna, U.O. Malattie Cardiovascolari, Policlinico Universitario Campus Germaneto | |
| Catanzaro, Italy, 88100 | |
| Centro per l'Ipertensione, Ospedale F. Veneziale | |
| Isernia, Italy, 86170 | |
| U.O.C. di Medicina Interna Universitaria 1, Ospedale San Salvatore | |
| L'Aquila, Italy, 67100 | |
| U.O. Nefrologia e Dialisi, Spedali Riuniti | |
| Livorno, Italy, 57100 | |
| U.O. Nefrologia e Dialisi, Università degli Studi di Milano Azienda Ospedaliera San Paolo | |
| Milano, Italy, 20142 | |
| Divisione di Nefrologia, Dialisi e Ipertensione Ospedale San Raffaele | |
| Milano, Italy, 20132 | |
| Clinica Medica 3, Dipartimento di Scienze Mediche e Chirurgiche | |
| Padova, Italy, 35128 | |
| Reparto Emodialisi, Clinica "Domus Nova" | |
| Ravenna, Italy, 48100 | |
| Nefrologia e Dialisi, Ospedale Infermi | |
| Rimini, Italy, 47900 | |
| Centro per l'Ipertensione, A.S.L. n° 1 | |
| Sassari, Italy, 07100 | |
| U.O. Nefrologia e Dialisi Presidio Ospedaliero "Giuseppe Mazzini" | |
| Teramo, Italy, 64100 | |
| Centro Ipertensione Arteriosa, SCU Medicina Interna 4, A.O.U. San Giovanni Battista | |
| Torino, Italy, 10126 | |
| Poland | |
| Institute of Cardiology, I Department of Cardiology and Hypertension, Jagiellonian University | |
| Krakow, Poland, 31-501 | |
| Internal Medicine and Gerontology, Jagiellonian University Medical College | |
| Krakow, Poland, 31-501 | |
| Institute of Cardiology, Department of Coronary Disease, Jagiellonian University | |
| Krakow, Poland, 31-202 | |
| Institute of Cardiology, Department of Hypertension, University of Medical Sciences | |
| Poznan, Poland, 01-848 | |
| The Cardinal Stefan Wyszynski Institute of Cardiology - Arterial Hypertension Clinic | |
| Warsaw, Poland, 04-628 | |
Sponsors and Collaborators
RostaQuo S.p.A.
Investigators
| Study Chair: | Jan A Staessen, MD PhD | Laboratory of Hypertension, University of Leuven, B-3000 Leuven - BELGIUM |
More Information
No publications provided
| Responsible Party: | Giovanni Valentini MD - Sponsor Medical Expert, RostaQuo S.p.A |
| ClinicalTrials.gov Identifier: | NCT01320397 History of Changes |
| Other Study ID Numbers: | PST 2238-DM-10-001, 2010-022073-34 |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 22, 2011 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Ireland: Irish Medicines Board |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents Losartan Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013