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

N/ACompletedNCT01420068

Noden Pharma106 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

106

Conditions

Hypertension

Interventions

SPP100DRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (25)

Novartis Investigative Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.