Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834041 | A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age | PHASE1 | COMPLETED | 39 | — | — | Apr 1, 2009 | Jan 1, 2010 | May 9, 2011 | 5 | United States, Belgium +3 |
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...