Clinical trial
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.
Name
CVT-CV-001
Description
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.
Trial arms
Trial start
2015-12-01
Estimated PCD
2018-02-08
Trial end
2018-02-08
Status
Completed
Phase
Early phase I
Treatment
Rostafuroxin
This is a potent, selective and safe inhibitor of this altered mechanism and has been proved to be effective in reducing blood pressure levels in Adducin mutated rat strains and in chronic Ouabain infused rat model.
Arms:
Rostafuroxin 50 micrograms capsules, Rostafuroxin 500 micrograms, Rostafuroxin 6 micrograms capsules
Other names:
Rosta
Losartan
COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a nonpeptide molecule, is chemically described as 2-butyl-4-chloro-1-\[p-(o-1H-tetrazol-5-ylphenyl)benzyl\]imidazole- 5-methanol monopotassium salt.
Arms:
Losartan 50 mg encapsulated
Size
240
Primary endpoint
Systolic Blood Pressure
Week 9 of treatment versus baseline
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ACTUAL'}}
Updated at
2023-02-21
1 organization
2 products
1 indication
Product
LosartanIndication
HypertensionOrganization
Windtree TherapeuticsProduct
Rostafuroxin