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Aliskiren 3.125 mini · 1 trial · 1 indication
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
| Arm | Type | Description |
|---|---|---|
| Aliskiren 2 mg/kg | EXPERIMENTAL | Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning |
| Aliskiren 6 mg/kg | EXPERIMENTAL | Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning |
| Name | Type | Description |
|---|---|---|
| Aliskiren 3.125 mini-tablets | DRUG | Oral mini-tablets (3.125 mg) of aliskiren once each morning |
Inclusion Criteria: * Male or female, 6-17 years of age * Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004) * Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization * Able to safely wash...
Aliskiren 3.125 mini is used for hypertension, a condition of high blood pressure. It is a small molecule being developed by Novartis AG for the cardiovascular therapeutic area. The drug is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for use.
Aliskiren 3.125 mini targets the renin-angiotensin system, specifically inhibiting renin, an enzyme involved in blood pressure regulation. By blocking 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 3.125 mini is developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of hypertension.
Aliskiren 3.125 mini is in Phase 1 clinical development. This early-stage trial focuses on evaluating the safety, tolerability, and pharmacokinetics of the drug. As an investigational drug, it has not yet received regulatory approval and is still undergoing clinical testing to determine its potential as a treatment for hypertension.
Aliskiren 3.125 mini has one completed clinical trial, identified as NCT00834041. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of aliskiren in hypertensive pediatric and adolescent patients aged 6 to 17 years. The trial enrolled 39 participants and was conducted in the United States, Belgium, Brazil, Hungary, and Poland.
Aliskiren 3.125 mini is a specific formulation or dosage strength of aliskiren, a drug used to treat hypertension. The clinical trial NCT00834041 evaluated aliskiren in pediatric patients, and the "3.125 mini" designation likely refers to a low-dose tablet formulation. Aliskiren is the active pharmaceutical ingredient, while the "mini" may indicate a smaller tablet size.