drugset / Trial / NCT01150357
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
RandomizedParallel-groupDouble-blindTreatment
Summary
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
Timeline
- Start
- 2010-06
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aliskiren | Small molecule | 6.25 mg | Oral |
| Subject | Aliskiren | Small molecule | 12.5 mg | Oral |
| Subject | Aliskiren | Small molecule | 25 mg | Oral |
| Subject | Aliskiren | Small molecule | 37.5 mg | Oral |
| Subject | Aliskiren | Small molecule | 75 mg | Oral |
| Subject | Aliskiren | Small molecule | 150 mg | Oral |
| Subject | Aliskiren | Small molecule | 300 mg | Oral |
| Subject | Aliskiren | Small molecule | 600 mg | Oral |