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52-104 Week Off-therapy Second Extension to Study CSPP100A2365

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: August 17, 2011
Last updated: October 4, 2016
Last verified: October 2016
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

Condition Intervention
Drug: SPP100

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: August 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients
All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.
Drug: SPP100


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric hypertensive patients 6 - 17 years of age previously treated with aliskiren in studies CSPP100A2365 and/or CSPP100A2365E1

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01420068

  Show 26 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01420068     History of Changes
Other Study ID Numbers: CSPP100A2365E2  2011-004411-22 
Study First Received: August 17, 2011
Last Updated: October 4, 2016
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control
Turkey: Ministry of Health
Hungary: National Institute of Pharmacy
Poland: The Central Register of Clinical Trials
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on October 21, 2016