Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aliskiren 150 · 1 trial · 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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Patients with essential hypertension * Patients with a BMI \> 25 kg/m2 * Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO Exclusion Criteria: * Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo...
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Aliskiren 150 is a small molecule renin inhibitor developed for the treatment of hypertension. It is also known as Aliskiren 150/300 mg, reflecting the two dose strengths studied. In clinical testing it has been evaluated in patients with essential hypertension, including overweight patients who also had left ventricular hypertrophy.
Aliskiren 150 targets renin, encoded by the REN gene, and acts as an inhibitor of that enzyme. By inhibiting renin, the drug is designed to reduce the activity of the renin-angiotensin system, which is a central pathway in blood pressure regulation. Its target class is therefore a renin inhibitor.
Aliskiren 150 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the clinical program evaluating the drug in hypertension.
Aliskiren 150 has been studied in Phase 3 clinical development. It is an investigational agent in this program rather than a newly approved product, and the Phase 3 trial that evaluated it has completed. No active trials of this asset are currently listed.
Aliskiren 150 was evaluated in the Phase 3 trial NCT00219141, titled Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension. The completed trial enrolled 460 participants across the United States, Argentina, Colombia, Finland, Germany, Italy, Russia, Spain, and Sweden.