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

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. Identifier: NCT01420068
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment
Hypertension Drug: SPP100

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Other
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
Actual Study Start Date : August 19, 2011
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren
U.S. FDA Resources

Group/Cohort Intervention/treatment
All patients
All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.
Drug: SPP100

Primary Outcome Measures :
  1. 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 ]

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

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

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 identifier (NCT number): NCT01420068

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01420068     History of Changes
Other Study ID Numbers: CSPP100A2365E2
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases