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 used for the treatment of essential hypertension, a condition of persistently high blood pressure. It is a fixed-dose combination product being developed as a small molecule therapy for cardiovascular use. The drug is intended to help manage blood pressure in patients with this condition.
Ali/Amlo 150 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for essential hypertension.
Ali/Amlo 150 is in Phase 3 of clinical development. This phase involves larger studies to confirm the drug's effectiveness, monitor side effects, and compare it with commonly used treatments. The drug is investigational and has not yet been approved by regulatory authorities for marketing.
Ali/Amlo 150 has one completed Phase 3 clinical trial registered under NCT01237873. The trial, titled "Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension," enrolled 150 participants in Japan. The study was uncontrolled and not randomized or double-blinded.
Yes, Ali/Amlo 150 is also known as SPA100. In clinical trial NCT01237873, the drug is referred to as SPA100, which is a fixed-dose combination of aliskiren and amlodipine. This alternative name may be used in scientific literature and regulatory documents.
Ali/Amlo 150 is a fixed-dose combination of aliskiren and amlodipine. Aliskiren is a direct renin inhibitor that reduces blood pressure by decreasing the production of angiotensin II, while amlodipine is a calcium channel blocker that relaxes blood vessels. Together, they help lower blood pressure in patients with essential hypertension.