Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03217825 | Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan | PHASE2 | COMPLETED | 240 | — | — | Dec 1, 2015 | Feb 8, 2018 | Feb 21, 2023 | 1 | Taiwan |
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.
| Arm | Type | Description |
|---|---|---|
| Rostafuroxin 6 micrograms capsules | EXPERIMENTAL | 1 capsule of ROSTAFUROXIN (6 micrograms) once a day before breakfast. |
| Rostafuroxin 50 micrograms capsules | EXPERIMENTAL | 1 capsule of ROSTAFUROXIN (50 micrograms) once a day before breakfast. |
| Rostafuroxin 500 micrograms | EXPERIMENTAL | 1 capsule of ROSTAFUROXIN (500 micrograms) once a day before breakfast. |
| Losartan 50 mg encapsulated | ACTIVE_COMPARATOR | 1 capsule containing one cpr of Losartan 50 mg once a day before breakfast. |
| Name | Type | Description |
|---|---|---|
| Rostafuroxin | DRUG | 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. |
| Losartan | DRUG | 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. |
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 a...