hypertension
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: aliskiren
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 6-
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 6 – 17 years of age (6 to less than 18 years of age at study completion) 2. Documented history of hypertension as defined in Section 5 3. Must be = 21.0 kg and = 100.0 kg at randomization (Visit 2) 4. Able to safely wash out antihypertensive therapy for 1 – 2 weeks 5. Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. An assent will be required for some patients depending upon their age and local requirements regarding assents. Informed consent must be obtained before any assessment is performed. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, please refer to the protocol. 1. Body weight of 100 kg (220 lbs.) 2. Inability to discontinue prior antihypertensive medication as required during the washout period 3. Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values, including but not limited to the following: • AST/SGOT or ALT/SGPT > 1.5 times the upper limit of the normal (ULN) reference range • Total bilirubin > 1.5 times the upper limit of normal • Creatinine clearance 5.3 mEq/L • Fasting glucose > 125 mg/dL (> 6.9 mmol/L) of the normal reference range 4. Renal artery stenosis 5. Current diagnosis of heart failure (NYHA Class II-IV) 6. msSBP = 25% above the 95th percentile for age, gender and height at Visit 2 7. Second or third degree heart block with or without a pacemaker 8. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1 9. Evidence of current symptomatic valvular disease 10. Previous solid organ transplantation or bone marrow transplant 11. Patients receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than inhaled/topical steroids, for any medical condition 12. Medical history of human immunodeficiency virus (HIV) and/or patient is concomitantly receiving anti-retroviral therapy 13. Medical history of hepatitis B and/or hepatitis C 14. Any clinically significant unstable medical condition or chronic disease that would put the patient at risk of experiencing an adverse event associated with the expected pharmacodynamic effects of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the safety and tolerability of aliskiren given as market formulation mini- tablets in hypertensive children, 6 to 17 years of age after single and multiple doses • To investigate the effect of age on pharmacokinetics of aliskiren given as market formulation mini-tablets in hypertensive children, from 6 to 17 years of age after single and multiple doses • To assess the dose proportionality on exposure after single and multiple doses ;Secondary Objective: • To assess the relationship between change in PRA and the dose of aliskiren (high dose 6mg/kg vs. low dose 2 mg/kg) in children with hypertension after single and multiple doses of aliskiren • To assess the relationship between PRA (change from baseline) and age in children with hypertension after single and multiple doses of aliskiren • To assess the relationship between change in blood pressure and change in PRA ;Primary end point(s): The primary end point is to demonstrate the safety and tolerability of aliskiren given as market formulation mini- tablets in hypertensive children, 6 to 17 years of age after single and multiple doses. | — |
Countries
Belgium, Hungary
Outcome results
None listed