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

Completed

• Conditions: Hypertension
• Interventions: Drug: SPP100

• Registration Number: NCT01420068
• Lead Sponsor: Noden Pharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-18
• Study Start: 2011-08-19
• Study First Posted: 2011-08-19
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-03
• Status Verified: 2018-09
• Results First Submitted: 2018-09-11
• Results First Submitted QC: 2018-09-21
• Results First Posted: 2019-02-15
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	SPP100	All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.

Primary Outcome Measures

Name	Time	Method
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)	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)	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.
Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)	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.
Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)	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).
Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS	Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group	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.	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).
Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group	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.	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.
Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group	Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.	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.
Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group	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.	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Ankara, Turkey