Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ali/Amlo 150 · 1 trial · 1 indication
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
| Arm | Type | Description |
|---|---|---|
| Ali/Amlo | EXPERIMENTAL | Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg |
| Name | Type | Description |
|---|---|---|
| Ali/Amlo 150/2.5 mg | DRUG | Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg |
Inclusion Criteria: * Patients that complete CSPA100A1301 study * Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled Exclusion Criteria: * Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study * Presence of major prot...
Ali/Amlo 150 is a fixed-dose combination small molecule therapy being developed by Novartis AG for essential hypertension. It combines aliskiren and amlodipine in a single oral product. The asset has completed Phase 3 clinical development, with one completed trial conducted in Japan.
Ali/Amlo 150 is being developed for the treatment of essential hypertension, a chronic cardiovascular condition. Its Phase 3 trial enrolled patients with essential hypertension in Japan. The program is a fixed-dose combination product rather than a single-agent therapy.
Ali/Amlo 150 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the Phase 3 program for this fixed-dose combination hypertension therapy.
Ali/Amlo 150 has completed Phase 3 clinical development. One Phase 3 trial has been completed and no trials are currently active. The program enrolled 150 patients in total, and the trial was conducted in Japan.
Ali/Amlo 150 has been studied in one Phase 3 trial, NCT01237873, titled Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension. The trial is completed, enrolled 150 patients, and was conducted in Japan.