A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Phase of Trial: Phase III
Latest Information Update: 15 Nov 2017
At a glance
- Drugs Aliskiren (Primary)
- Indications Hypertension
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Novartis
- 15 Nov 2017 According to a Noden Pharma media release, the US Food and Drug Administration has approved Aliskiren oral pellets for the treatment of hypertension in adults and children six years of age and older. The new pellet formulation and pediatric indication were approved through the FDA priority review process.
- 27 Aug 2014 Status changed from recruiting to completed according to ClinicalTrials.gov record.
- 15 Apr 2014 Planned End Date changed from 1 Jun 2014 to 1 Aug 2014, as per ClinicalTrials.gov record.