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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01420068
First received: August 17, 2011
Last updated: January 21, 2014
Last verified: January 2014
  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
Hypertension

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 ]

Estimated Enrollment: 18
Study Start Date: August 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
All patients
All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420068

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300

Locations
United States, Oregon
Investigative Site Recruiting
Portland, Oregon, United States
Contact: Novartis    862-778-8300      
Belgium
Investigative Site Recruiting
Brussels, Belgium
Contact: Novartis    862-778-8300      
France
Investigative Site Recruiting
Paris, France
Contact: Novartis    862-778-8300      
Germany
Investigative Site Recruiting
Berlin, Germany
Contact: Novartis    862-778-8300      
Hungary
Investigative Site Recruiting
Budapest, Hungary
Contact: Novartis    862-778-8300      
Poland
Investigative Site Recruiting
Warsaw, Poland
Contact: Novartis    862-778-8300      
Slovakia
Investigative Site Recruiting
Bratislava, Slovakia
Contact: Novartis Pharmaceuticals    862-778-8300      
Turkey
Investigative Site Recruiting
Ankara, Turkey
Contact: Novartis    862-778-8300      
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01420068     History of Changes
Other Study ID Numbers: CSPP100A2365E2
Study First Received: August 17, 2011
Last Updated: January 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control
United States: Food and Drug Administration
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:
Pediatric
hypertension
aliskiren

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014