N/A
Completed N=106
52-104 Week Off-therapy Second Extension to Study CSPP100A2365
Source: ClinicalTrials.gov NCT01420068 ↗Enrolled (actual)
106
Serious AEs
0.9%
Results posted
Feb 2019
Primary outcomePrimary: 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) — 8.90; 9.22 kg — p=0.840
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
8.90; 9.22 | 0.840 |
| PRIMARY Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS |
7.27; 7.96 | 0.303 |
| PRIMARY Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS |
1.53; 1.56 | 0.957 |
| PRIMARY Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS |
8; 4; 0; 1; 0; 1 | — |
| SECONDARY Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group |
8.31; 8.33; -0.73; -3.80 | 0.992 |
| SECONDARY Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group |
6.80; 7.42; 16.05; 16.96 | 0.403 |
| SECONDARY Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group |
1.30; 1.19; -1.81; -2.97 | 0.860 |
| SECONDARY Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group |
7; 5; 1; 0; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01420068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.