Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aliskiren/amlodipine 300 · 1 trial · 1 indication
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
| Arm | Type | Description |
|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | EXPERIMENTAL | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. |
| Amlodipine 10 mg capsule | ACTIVE_COMPARATOR | Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. |
| Name | Type | Description |
|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | DRUG | Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. |
| Amlodipine 10 mg capsule | DRUG | Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. |
Inclusion Criteria: * Outpatients ≥ 18 years of age * Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \< 200 mmHg at Visit 2 Exclusion Criteria: * Mild to moderate hypertension * Pregnant or nursing (lactating) women * Women of child-bearing potential...
Aliskiren is an investigational small molecule being developed for cardiovascular conditions, including essential hypertension, moderate to severe hypertension, high blood pressure, myocardial infarction, diabetic nephropathy, and post acute coronary syndrome. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Aliskiren is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical trials for multiple cardiovascular indications.
Aliskiren is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The development program includes completed Phase 1, Phase 2, and Phase 3 trials across various cardiovascular conditions.
Aliskiren has completed 39 clinical trials with a total enrollment of 29,180 participants. Notable trials include NCT00853827, a Phase 3 study in coronary artery disease patients, and NCT00311012, a Phase 2 dose-finding study in Japanese hypertension patients.
Yes, Aliskiren is also known as SPP100. Clinical trial NCT00311012, titled 'SPP100 Dose Finding Study in Japan,' investigated the drug in 445 patients with hypertension, confirming that SPP100 is an alternative name for Aliskiren.