This trial is active, not recruiting.

Condition hypertension
Treatment spp100
Sponsor Novartis Pharmaceuticals
Start date August 2011
End date August 2017
Trial size 106 participants
Trial identifier NCT01420068, 2011-004411-22, CSPP100A2365E2


52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and development in pediatric hypertensive patients previously treated with aliskiren in studies SPP100A2365 and SPP100A2365E1

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.

Primary Outcomes

Long term growth and development of pediatric hypertensive patients aged 6 - 17 years when treated previously with aliskiren; measured by height and weight changes and changes in neurocognitive development
time frame: 1-2 years

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

Inclusion Criteria: - Successful completion of study CSPP100A2365E1 - Patients must meet inclusion criteria set forth for trials CSPP100A2365 and CSPP100A2365E1 - Informed consent/ patient assent Exclusion Criteria: •Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1

Additional Information

Official title A Multicenter, Double-blind 52 to 104 Week Off-therapy Extension Study to Evaluate the Long Term Growth and Development of Pediatric Hypertensive Patients 6 - 17 Years of Age Previously Treated With Aliskiren in Studies CSPP100A2365 and/or CSPP100A2365E1
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Novartis.