Clinical trial NCT01420068: 52-104 Week Off-therapy Second Extension to Study CSPP100A2365
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Pediatric
hypertension
aliskiren
Lead sponsor: Noden Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 106
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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


Eligibility 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

Primary outcomes:
measure: Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the Enrolled to Follow-up Set (EFS)
timeFrame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
measure: Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS
timeFrame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
measure: Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS
timeFrame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
measure: Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS
timeFrame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Secondary outcomes:
measure: Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group
timeFrame: Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
measure: Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group
timeFrame: Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
measure: Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group
timeFrame: Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
measure: Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group
timeFrame: Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Dalton
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Lewiston
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Hattiesburg
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Amarillo
country: United States
facility: Novartis Investigative Site
state: Texas
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Myjava
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: