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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05288400 | Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension. | PHASE3 | COMPLETED | 150 | — | — | May 14, 2018 | Dec 18, 2018 | Jun 5, 2025 | 15 | Russia |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | single-capsule of fixed dosed combination (FDC) of amlodipine 5 mg / bisoprolol fumarate 5 mg / perindopril arginine 5 mg |
| Group B | ACTIVE_COMPARATOR | Free triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly |
| Name | Type | Description |
|---|---|---|
| Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg | COMBINATION_PRODUCT | 1 capsule/day Oral administration |
| Norvasc 5mg tablet | DRUG | Norvasc (amlodipine) 5mg, 1 tablet/day |
| Concor 5mg tablet | DRUG | Concor (bisoprolol fumarate) 5mg, 1 tablet/day |
| Coversyl 5mg tablet | DRUG | Coversyl (perindopril arginine) 5mg, 1 tablet/day |
Selection criteria: * Men or women of any ethnic origin ≥18 years old who signed Informed consent form. * Patients with uncontrolled hypertension defined by SBP ≥140 and \< 160 mmHg and DBP ≥90 and \< 100 mmHg already treated by anti-hypertensive monotherapy at maximal dose or either by a dual ther...