Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ · 4 trials · 1 indication
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. |
| Aliskiren 150 mg | ACTIVE_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. |
| Amlodipine 2.5 mg | ACTIVE_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. |
| Amlodipine 5 mg | ACTIVE_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Aliskiren/amlodipine 150/2.5 mg | EXPERIMENTAL | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. |
| Aliskiren/amlodipine 150/5 mg | EXPERIMENTAL | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Non responder Olmesartan/Amlodipine | EXPERIMENTAL | Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ |
| Aliskiren/Amlodipine/Hydrochlorothiazide | EXPERIMENTAL | Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning. |
| Name | Type | Description |
|---|---|---|
| Aliskiren/Amlodipine 150/2.5 mg | DRUG | Aliskiren/amlodipine 150/2.5 mg tablet |
| Aliskiren/amlodipine 150/5 mg | DRUG | Aliskiren/amlodipine 150/5 mg tablet |
| Aliskiren 150 mg | DRUG | Aliskiren 150 mg tablet |
| Amlodipine 2.5 mg | DRUG | Amlodipine 2.5 mg capsule |
| Placebo of Aliskiren | DRUG | Aliskiren placebo tablet |
| Placebo of Amlodipine | DRUG | Amlodipine placebo capsule |
| Placebo of Aliskiren/amlodipine 150/2.5 mg | DRUG | Aliskiren/amlodipine 150/2.5 mg placebo tablet |
| Placebo of Aliskiren/amlodipine 150/5 mg | DRUG | Aliskiren/amlodipine 150/5 mg placebo tablet |
| Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ | DRUG | Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg |
| Aliskiren | DRUG | 300 mg tablet |
| Amlodipine | DRUG | 5 mg tablet |
| Hydrochlorothiazide | DRUG | 12.5 mg and 25 mg capsule |
Inclusion Criteria: * Patients with essential hypertension (msDBP ≥ 95 mmHg and \< 110 mmHg and msSBP ≥140 mmHg ) * Outpatients Exclusion Criteria: * Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg) * History of allergy or hypersensitivity to renin inhibitors, calcium channel blocker...
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.