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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06236061 | Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy | PHASE3 | COMPLETED | 718 | — | — | Apr 8, 2024 | Dec 23, 2025 | Jan 13, 2026 | 43 | Japan |
Change from baseline to Week 8 in mean sitting systolic blood pressure (msSBP)
| Arm | Type | Description |
|---|---|---|
| LCZ 200mg | ACTIVE_COMPARATOR | Oral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine placebo daily. |
| LCZ 200mg + AML 2.5mg | EXPERIMENTAL | Oral administration, 1 tablet of LCZ 200 mg daily, 1 capsule of Amlodipine 2.5 mg daily and 3 capsules of Amlodipine placebo daily. |
| LCZ 200mg + AML 5mg | EXPERIMENTAL | Oral administration, 1 tablet of LCZ 200 mg daily, 2 capsules of Amlodipine 2.5 mg daily and 2 capsules of Amlodipine placebo daily. |
| LCZ 200mg + AML 10mg | EXPERIMENTAL | Oral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine 2.5 mg daily. |
| Name | Type | Description |
|---|---|---|
| LCZ | DRUG | LCZ 200 mg |
| LCZ/AML 200 mg/2.5 mg | DRUG | LCZ/AML 200 mg/2.5 mg |
| LCZ/AML 200 mg/5 mg | DRUG | LCZ/AML 200 mg/5 mg |
| LCZ/AML 200 mg/10 mg | DRUG | LCZ/AML 200 mg/10 mg |
| Placebo | OTHER | Matching placebo of Amlodipine. |
Inclusion Criteria: Core Part) * Patients with grade 1 and 2 essential hypertension, untreated or currently taking antihypertensive therapy 1. Untreated patients \[either newly diagnosed with essential hypertension or those with a history of hypertension but have not been taking any antihyperte...