Hypertension
Conditions
Keywords
Pediatric, hypertension, aliskiren
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
Interventions
DRUGSPP100
Sponsors
Noden Pharma
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Guatemala, Hungary, Poland, Puerto Rico, Slovakia, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enalapril No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of enalapril based on their weight: low weight (≥20 to \<50 kg) participants - starting dose 2.5 mg with optional titration to 5 and then 10 mg; mid weight (≥50 to \<80 kg) participants - starting dose 5 mg with optional titration to 10 and then 20 mg; high weight (≥80 to ≤150 kg) participants - starting dose 10 mg with optional titration to 20 and then 40 mg. | 51 |
| Aliskiren No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of aliskiren based on their weight: low weight (≥20 to \<50 kg) participants - starting dose 37.5 mg with optional titration to 75 and then 150 mg; mid weight (≥50 to \<80 kg) participants - starting dose 75 mg with optional titration to 150 and then 300 mg; high weight (≥80 to ≤150 kg) participants - starting dose 150 mg with optional titration to 300 and then 600 mg. | 55 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problems | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Enalapril | Aliskiren |
|---|---|---|---|
| Age, Continuous | 11.4 years STANDARD_DEVIATION 3.25 | 11.5 years STANDARD_DEVIATION 3.32 | 11.4 years STANDARD_DEVIATION 3.21 |
| Age, Customized Age group Adolescents 12 - 17 years | 48 Participants | 23 Participants | 25 Participants |
| Age, Customized Age group Children 6 - 11 years | 58 Participants | 28 Participants | 30 Participants |
| BMI category < 95th percentile | 101 Participants | 49 Participants | 52 Participants |
| BMI category >= 95th percentile | 5 Participants | 2 Participants | 3 Participants |
| Body mass index (BMI) | 26.1 kg/m^2 STANDARD_DEVIATION 7.81 | 26.1 kg/m^2 STANDARD_DEVIATION 7.58 | 26.1 kg/m^2 STANDARD_DEVIATION 8.09 |
| eGFR category >= 60 and < 90 mL/min/1.73m^2 | 16 Participants | 11 Participants | 5 Participants |
| eGFR category < 60 mL/min/1.73m^2 | 1 Participants | 1 Participants | 0 Participants |
| eGFR category >= 90 mL/min/1.73m^2 | 89 Participants | 39 Participants | 50 Participants |
| Estimated glomerular filtration rate (eGFR) | 108.3 mL/min/1.73m^2 STANDARD_DEVIATION 22.43 | 104.2 mL/min/1.73m^2 STANDARD_DEVIATION 24.86 | 112.1 mL/min/1.73m^2 STANDARD_DEVIATION 19.39 |
| Height | 151.1 cm STANDARD_DEVIATION 19.92 | 151.9 cm STANDARD_DEVIATION 20.72 | 150.4 cm STANDARD_DEVIATION 19.31 |
| Hypertension etiology Primary | 87 Participants | 41 Participants | 46 Participants |
| Hypertension etiology Secondary | 19 Participants | 10 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Chinese | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 23 Participants | 14 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Indian (Indian subcontinent) | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Japanese | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed ethnicity | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 79 Participants | 36 Participants | 43 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 15 Participants | 8 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 71 Participants | 30 Participants | 41 Participants |
| Sex: Female, Male Female | 42 Participants | 19 Participants | 23 Participants |
| Sex: Female, Male Male | 64 Participants | 32 Participants | 32 Participants |
| Weight | 63.2 kg STANDARD_DEVIATION 30.03 | 63.8 kg STANDARD_DEVIATION 29.99 | 62.6 kg STANDARD_DEVIATION 30.33 |
| Weight category >= 20 kg and < 50 kg | 45 Participants | 21 Participants | 24 Participants |
| Weight category >= 50 kg and < 80 kg | 31 Participants | 14 Participants | 17 Participants |
| Weight category >= 80 kg and <= 150 kg | 30 Participants | 16 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 55 |
| other Total, other adverse events | 0 / 51 | 0 / 55 |
| serious Total, serious adverse events | 1 / 51 | 0 / 55 |
Outcome results
Primary
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)
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Enalapril | 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 kg/m^2 | Standard Error 0.487 |
| Aliskiren | Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | 1.56 kg/m^2 | Standard Error 0.502 |
p-value: 0.95795% CI: [-1.06, 1.12]ANCOVA
Primary
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)
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Enalapril | 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 cm | Standard Error 0.586 |
| Aliskiren | Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | 7.96 cm | Standard Error 0.607 |
p-value: 0.30395% CI: [-0.63, 2.02]ANCOVA
Primary
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.
Time frame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is those with secondary hypertension and both baseline and LT Visit 18 observations for that test.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Right hand | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Forward raw score | Negative change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Backward raw score | Positive change | 5 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Backward raw score | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Number correct | Positive change | 7 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Timed gait: Number of seconds | No change | 3 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Forward raw score | Positive change | 8 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Forward raw score | No change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Backward raw score | No change | 2 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Number correct | No change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Number correct | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Time to complete (sec) | Positive change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Time to complete (sec) | No change | 7 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Time to complete (sec) | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Sequences: Total raw score | Positive change | 6 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Sequences: Total raw score | No change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Sequences: Total raw score | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Right hand | Positive change | 7 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Right hand | No change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Left hand | Positive change | 4 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Left hand | No change | 3 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Left hand | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Timed gait: Number of seconds | Positive change | 4 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Timed gait: Number of seconds | Negative change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Timed gait: Number of seconds | Negative change | 2 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Forward raw score | No change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Time to complete (sec) | Negative change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Left hand | Positive change | 2 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Sequences: Total raw score | Positive change | 6 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Backward raw score | Negative change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Timed gait: Number of seconds | Positive change | 3 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Time to complete (sec) | Positive change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Right hand | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Sequences: Total raw score | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Left hand | No change | 2 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Sequences: Total raw score | Negative change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Forward raw score | Negative change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Backward raw score | Positive change | 4 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Timed gait: Number of seconds | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Backward raw score | No change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Number correct | Positive change | 6 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Right hand | Positive change | 3 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Number correct | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Left hand | Negative change | 2 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Number correct | Negative change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Numbers: Forward raw score | Positive change | 4 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Time tapping: Right hand | Negative change | 3 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS | Visual matching: Time to complete (sec) | No change | 6 Participants |
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)
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)
Population: The EFS consisted of all participants who signed the informed consent form (ICF) for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Enalapril | 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 kg | Standard Error 1.359 |
| Aliskiren | 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) | 9.22 kg | Standard Error 1.399 |
p-value: 0.8495% CI: [-2.74, 3.37]ANCOVA
Secondary
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.
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at EOS. EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Enalapril | Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Primary Hypertension Group | 1.30 kg/m^2 | Standard Error 0.428 |
| Enalapril | Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Secondary Hypertension Group | -1.81 kg/m^2 | Standard Error 1.336 |
| Aliskiren | Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Primary Hypertension Group | 1.19 kg/m^2 | Standard Error 0.424 |
| Aliskiren | Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Secondary Hypertension Group | -2.97 kg/m^2 | Standard Error 1.397 |
Comparison: Primary Hypertension group (at LT Visit 18 \[Week 104\])p-value: 0.8695% CI: [-1.29, 1.08]ANCOVA
Comparison: Secondary hypertension group (at LT Visit 19 \[Week 156\])p-value: 0.3295% CI: [-3.66, 1.32]ANCOVA
Secondary
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).
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.
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at EOS. EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Enalapril | Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Primary Hypertension Group | 6.80 cm | Standard Error 0.529 |
| Enalapril | Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Secondary Hypertension Group | 16.05 cm | Standard Error 3.316 |
| Aliskiren | Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Primary Hypertension Group | 7.42 cm | Standard Error 0.528 |
| Aliskiren | Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Secondary Hypertension Group | 16.96 cm | Standard Error 3.044 |
Comparison: Primary Hypertension group (at LT Visit 18 \[Week 104\])p-value: 0.40395% CI: [-0.85, 2.09]ANCOVA
Comparison: Secondary hypertension group (at LT Visit 19 \[Week 156\])p-value: 0.6795% CI: [-3.74, 5.57]ANCOVA
Secondary
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.
Time frame: Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is those with secondary hypertension and both baseline and LT Visit 19 observations for that test.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Right hand | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Forward raw score | Positive change | 7 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Forward raw score | No change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Forward raw score | Negative change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Backward raw score | Positive change | 5 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Backward raw score | No change | 2 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Backward raw score | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Number correct | Positive change | 6 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Number correct | No change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Number correct | Negative change | 2 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Time to complete (sec) | Positive change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Time to complete (sec) | No change | 7 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Time to complete (sec) | Negative change | 1 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Sequences: Total raw score | Positive change | 8 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Sequences: Total raw score | No change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Sequences: Total raw score | Negative change | 0 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Right hand | Positive change | 5 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Right hand | No change | 2 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Left hand | Positive change | 2 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Left hand | No change | 3 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Left hand | Negative change | 3 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Timed gait: Number of seconds | Positive change | 4 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Timed gait: Number of seconds | No change | 2 Participants |
| Enalapril | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Timed gait: Number of seconds | Negative change | 2 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Right hand | Negative change | 4 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Left hand | Negative change | 3 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Time to complete (sec) | Negative change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Forward raw score | Positive change | 5 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Timed gait: Number of seconds | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Forward raw score | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Sequences: Total raw score | Positive change | 6 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Forward raw score | Negative change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Left hand | Positive change | 2 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Backward raw score | Positive change | 4 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Sequences: Total raw score | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Backward raw score | No change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Timed gait: Number of seconds | Positive change | 3 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Numbers: Backward raw score | Negative change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Sequences: Total raw score | Negative change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Number correct | Positive change | 6 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Left hand | No change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Number correct | No change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Timed gait: Number of seconds | Negative change | 3 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Number correct | Negative change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Right hand | No change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Time to complete (sec) | Positive change | 0 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Time tapping: Right hand | Positive change | 1 Participants |
| Aliskiren | Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group | Visual matching: Time to complete (sec) | No change | 6 Participants |
Secondary
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.
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.
Population: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at EOS. EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Enalapril | Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group | Primary Hypertension Group | 8.31 kg | Standard Error 1.195 |
| Enalapril | Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group | Secondary Hypertension Group | -0.73 kg | Standard Error 3.699 |
| Aliskiren | Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group | Primary Hypertension Group | 8.33 kg | Standard Error 1.182 |
| Aliskiren | Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group | Secondary Hypertension Group | -3.80 kg | Standard Error 3.445 |
Comparison: Secondary hypertension group (at LT Visit 19 \[Week 156\])p-value: 0.21595% CI: [-8.22, 2.1]ANCOVA
Comparison: Primary Hypertension group (at LT Visit 18 \[Week 104\])p-value: 0.99295% CI: [-3.29, 3.33]ANCOVA