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Also known as Aliskiren 3.125 mini-tablets
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...
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Aliskiren 3.125 mini is an investigational low-dose formulation of aliskiren studied for the treatment of hypertension. It was evaluated in pediatric and adolescent patients aged 6 to 17 years with high blood pressure. The mini-tablet format is designed to deliver a 3.125 mg dose of aliskiren.
Aliskiren 3.125 mini targets renin, encoded by the REN gene. It acts as a renin inhibitor, a small molecule that blocks the renin enzyme at the start of the renin-angiotensin system, which regulates blood pressure and fluid balance. Inhibiting renin reduces production of angiotensin and lowers blood pressure.
Aliskiren 3.125 mini is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this low-dose aliskiren mini-tablet formulation in hypertensive pediatric and adolescent patients.
Aliskiren 3.125 mini is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 program assessed safety, tolerability, and pharmacokinetics in children and adolescents with hypertension.
Aliskiren 3.125 mini was studied in one completed Phase 1 trial, NCT00834041, titled a study to evaluate the safety, tolerability, and pharmacokinetics of aliskiren in hypertensive pediatric and adolescent patients 6 to 17 years of age. The randomized, controlled trial enrolled 39 patients across the United States, Belgium, Brazil, Hungary, and Poland.
Yes, Aliskiren 3.125 mini and Aliskiren 3.125 mini-tablets refer to the same investigational product from Novartis. The mini-tablet name describes the low-dose 3.125 mg oral formulation of aliskiren developed for pediatric and adolescent hypertension patients.