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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420068
First Posted: August 19, 2011
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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
Hypertension 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 ( Novartis Pharmaceuticals ):

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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420068


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01420068     History of Changes
Other Study ID Numbers: CSPP100A2365E2
2011-004411-22
First Submitted: August 17, 2011
First Posted: August 19, 2011
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pediatric
hypertension
aliskiren

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases