An 8 day open-label, multiple-dose, multi-center study to evaluate the safety/tolerability and pharmacokinetics of aliskiren in hypertensive pediatric and adolescent patients 6 – 17 years of age.
- Conditions
- hypertension
- Registration Number
- EUCTR2008-005802-37-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
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
For full list, please refer to the protocol.
1. Body weight of < 21 kg (46 lbs.) or > 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 <50 mL/min/1.73m² (based on the serum creatinine concentration obtained at the screening visit calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR])
• WBC count < 3000/mm³
• Platelet count < 100,000/mm³
• Serum potassium > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method