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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: SPP100

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1131
    • Novartis Investigative Site
  • Nyiregyhaza, Hungary, 4400
    • Novartis Investigative Site
  • Szeged, Hungary, 6725
    • Novartis Investigative Site
  • Veszprem, Hungary, H-8200
    • Novartis Investigative Site
• Poland
  • Warsaw, Poland, 03 - 335
    • Novartis Investigative Site
• Puerto Rico
  • San Juan, Puerto Rico, 00907
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 85107
    • Novartis Investigative Site
  • Martin, Slovakia, 03601
    • Novartis Investigative Site
  • Myjava, Slovakia, 90701
    • Novartis Investigative Site
  • Presov, Slovakia, 08001
    • Novartis Investigative Site
  • Trnava, Slovakia, 91701
    • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06500
    • Novartis Investigative Site
  • Ankara, Turkey, 06490
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0006
      • Novartis Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Novartis Investigative Site
  • Georgia
    • Dalton, Georgia, United States, 30721
      • Novartis Investigative Site
  • Idaho
    • Lewiston, Idaho, United States, 83501
      • Novartis Investigative Site
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Novartis Investigative Site
    • Jackson, Mississippi, United States, 39209
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10016
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97225
      • Novartis Investigative Site
    • Portland, Oregon, United States, 07227
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Novartis Investigative Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS	Participant height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension).	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS	Participant height and weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). BMI was derived.	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS	All participants who were determined to have secondary hypertension in the core study and had a Baseline (Visit 2) standardized neurocognitive assessment in the core study received follow-up neurocognitive assessments at LT Visit 18 and LT Visit 19 with the same tool. The neurocognitive assessment of development included assessment of the following abilities: Attention, Processing speed, Working memory, and Motor speed. For Numbers (Forward and Backward Raw Score), Visual Matching (Number Correct), Sequences (Total Raw Score): positive change indicates a numerical increase, which is considered a better outcome/improvement; negative change/numerical decrease is considered a worse outcome/decline. For Visual Matching (Time to Complete), Time Tapping (Right and Left Hands), and Timed Gait: positive change indicates a numerical increase, which is considered a worse outcome/decline; negative change/numerical decrease is considered a better outcome/improvement.	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group	Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.	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.
Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group	Participant height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension).	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.
Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group	Participant weight and height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes. BMI was derived.	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.
Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group	All participants who were determined to have secondary hypertension in the core study and had a Baseline (Visit 2) standardized neurocognitive assessment in the core study received follow-up neurocognitive assessments at LT Visit 18 and LT Visit 19 with the same tool. The neurocognitive assessment of development included assessment of the following abilities: Attention, Processing speed, Working memory, and Motor speed. For Numbers (Forward and Backward Raw Score), Visual Matching (Number Correct), Sequences (Total Raw Score): positive change indicates a numerical increase, which is considered a better outcome/improvement; negative change/numerical decrease is considered a worse outcome/decline. For Visual Matching (Time to Complete), Time Tapping (Right and Left Hands), and Timed Gait: positive change indicates a numerical increase, which is considered a worse outcome/decline; negative change/numerical decrease is considered a better outcome/improvement.	Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.

Collaborators and Investigators

• Sponsor: Noden Pharma

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2011
• Primary Completion (Actual): August 3, 2017
• Study Completion (Actual): August 3, 2017

Study Registration Dates

• First Submitted: August 17, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (Estimate): August 19, 2011

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; hypertension; aliskiren
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CSPP100A2365E2; 2011-004411-22