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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014