Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aliskiren 150 · 2 trials · 3 indications
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
| Arm | Type | Description |
|---|---|---|
| Amlodipine 10 mg | EXPERIMENTAL | Amlodipine 10 mg |
| Aliskiren/Amlodipine 150/10 mg | EXPERIMENTAL | Aliskiren/Amlodipine 150/10 mg |
| Aliskiren/Amlodipine 300/10 mg | EXPERIMENTAL | Aliskiren/Amlodipine 300/10 mg |
| Aliskiren 300 mg | EXPERIMENTAL | Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Losartan 100 mg | ACTIVE_COMPARATOR | Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Aliskiren/losartan 300/100 mg | EXPERIMENTAL | Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Name | Type | Description |
|---|---|---|
| Amlodipine 10 mg | DRUG | Amlodipine 10 mg |
| Aliskiren 150 | DRUG | Aliskiren/Amlodipine 150/10 mg |
| Amlodipine 300 | DRUG | Aliskiren/Amlodipine 300/10 mg |
| Aliskiren 150/300 mg | DRUG | Aliskiren 150 mg tablets |
| Losartan 50/100 mg | DRUG | Losartan 50 or 100 mg capsules |
| Aliskiren placebo | DRUG | Aliskiren 150 mg placebo tablet |
| Losartan 50/100 mg placebo | DRUG | Losartan 50/100 mg placebo capsules |
Inclusion Criteria: * Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2 * Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a m...
Aliskiren 150 is an investigational small molecule being developed for hypertension, a cardiovascular condition. It is a direct renin inhibitor that works by blocking the action of renin, an enzyme involved in blood pressure regulation. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Aliskiren 150 targets renin, an enzyme that plays a key role in the renin-angiotensin system, which regulates blood pressure. By inhibiting renin, the drug aims to reduce the production of angiotensin II, a hormone that causes blood vessels to constrict, thereby helping to lower blood pressure in patients with hypertension.
Aliskiren 150 is being developed by Novartis AG, a multinational pharmaceutical company. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with hypertension. Novartis is listed on the stock exchange under the ticker symbol NVS.
Aliskiren 150 is in Phase 3 clinical development. This phase involves large-scale studies to confirm the drug's effectiveness, monitor side effects, and compare it with commonly used treatments. The drug is still investigational and has not yet received approval from regulatory agencies such as the FDA.
Aliskiren 150 has been studied in two completed Phase 3 clinical trials. NCT00219141 evaluated the drug in combination with losartan for left ventricular hypertrophy in overweight patients with hypertension, enrolling 460 participants. NCT00778921 assessed the efficacy and safety of combining aliskiren with amlodipine in patients not adequately responding to amlodipine alone, enrolling 847 participants.
Aliskiren 150 is a formulation of the drug aliskiren, which is also known by the brand name Tekturna. The 150 mg dose is a specific strength of this medication. While the data provided does not explicitly mention Tekturna, aliskiren is the active ingredient in both, and they are used for the same indication of hypertension.