Phase 2
Completed N=39
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Source: ClinicalTrials.gov NCT00834041 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
May 2011
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients — 76.8; 393.3; 82.2; 397.1 ng/ml
Summary
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients |
76.8; 393.3; 82.2; 397.1; 136.5; 424.3 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients |
278.3; 1231.0; 403.6; 1959.9; 390.9; 1808.7 | — |
| PRIMARY Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients |
9694.0; 3905.4; 5388.1; 3539.0 | — |
| SECONDARY Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9 |
-1.8; -4.0; -1.8; -3.8; -1.3; -3.5 | — |
| SECONDARY Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients |
-4.5; -7.7; -7.6; -7.7; -1.7; 0.0 | — |
Eligibility Criteria
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 out previous antihypertensive therapy for 1-2 weeks
Exclusion Criteria
- Body weight of 100 kg (220 lbs)
- Inability to discontinue prior antihypertensive medication as required during the washout period
- Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
- Renal artery stenosis
- Current diagnosis of heart failure (NYHA Class II-IV)
- msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
- Second or third degree heart block with or without a pacemaker
- Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
- Evidence of current symptomatic valvular disease
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00834041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.