A multicenter, double-blind, randomized, 52 week extension study to evaluate the long term safety, tolerability and efficacy of aliskiren compared to enalapril in pediatric hypertensive patients 6-17 years of age

Conditions: Hypertension
MedDRA version: 17.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders

Registration Number: EUCTR2009-017029-20-SK

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
• Informed consent form (approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)) signed by the parent(s)/legal guardian(s), after the purpose and nature of the investigation has been clearly explained to the parents and the patient, and prior to any study procedure for the extension study. An assent may be required for some patients depending upon their age and the local requirements regarding assents.
• Male or female, ages 6-17 years old, i.e. age at Visit 2 (randomization), in study
CSPP100A2365, with a documented diagnosis of hypertension as defined in the NHLBI 4th Report 2004
• msSBP (mean of 3 systolic blood pressure measurements) must be = 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
• Must be = 20 kg and = 150 kg at Visit 2 (randomization), in study CSPP100A2365
• Must be able to swallow minitablets (2mm in diameter) administered in soft food
• Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious and drug-related adverse event(s).
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

• Patients who experienced any adverse event(s) considered serious and drug-related, in study CSPP100A2365,
are excluded from participation in study CSPP100A2365E1
• Any clinically significant abnormalities or clinically noteworthy abnormal laboratory
values (other than those relating to renal function) at Visit 2 baseline (CSPP100A2365), including but not limited
to the following:
• AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
• Total bilirubin > 2 times the upper limit of the reference range
• Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz
formula to estimate glomerular filtration rate [GFR]), based on based on the serum
Creatinine concentration obtained at the screening visit
• WBC count < 3000/mm³
• Platelet count < 100,000/mm³
• Serum potassium > 5.2 mEq/L
• Renal artery stenosis
• History of angioedema
• Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or
obstructive valvular disease
• msSBP = 25% above the 95th percentile
• Second or third degree heart block without a pacemaker
• Atrial fibrillation or atrial flutter at Visit 1 or 6 of CSPP100A2365, or potentially life threatening, or any
symptomatic arrhythmia during the 12 months prior to Visit 1 of CSPP100A2365
• Previous solid organ transplantation
• Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids,
for any medical condition
• Human immunodeficiency virus (HIV) by history and/or the patient is concomitantly
receiving anti-retroviral therapy for the treatment of HIV
• 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
• Any surgical or medical condition or concomitant medication which might significantly
alter the absorption, distribution, metabolism, or excretion of study medication including, but not limited to, any
of the following:
• History of major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection
• Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 of
CSPP100A2365
• Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months
prior to Visit 1 of CSPP100A2365
• Active pancreatic injury, pancreatitis or evidence of impaired pancreatic
function/injury as indicated by medical history of abnormal lipase or amylase
• History of hepatic encephalopathy, a history of esophageal varices, or a history of
portocaval shunt
• Current obstruction of the urinary tract or difficulty in voiding due to mechanical or inflammatory
conditions which is likely to require intervention during the course of the study or is regarded as clinically
meaningful by the investigator
• Current treatment with cyclosporine, atorvastatin, cholestyramine or colestipol resins, monoamine oxidase
(MAO) inhibitors, ketoconazole, itraconazole or antiarrhythmic medications (other than digoxin)
For a complete list of the exclusion criteria, please refer to protocol.