Trial Outcomes & Findings for 52-104 Week Off-therapy Second Extension to Study CSPP100A2365 (NCT NCT01420068)
NCT ID: NCT01420068
Last Updated: 2019-03-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
106 participants
Primary outcome timeframe
Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
55
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Administrative problems
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
52-104 Week Off-therapy Second Extension to Study CSPP100A2365
Baseline characteristics by cohort
| Measure |
Enalapril
n=51 Participants
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.
|
Aliskiren
n=55 Participants
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.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.5 years
STANDARD_DEVIATION 3.32 • n=99 Participants
|
11.4 years
STANDARD_DEVIATION 3.21 • n=107 Participants
|
11.4 years
STANDARD_DEVIATION 3.25 • n=206 Participants
|
|
Age, Customized
Age group · Children 6 - 11 years
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Customized
Age group · Adolescents 12 - 17 years
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed ethnicity
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
36 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Chinese
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Indian (Indian subcontinent)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Japanese
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Hypertension etiology
Primary
|
41 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Hypertension etiology
Secondary
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Height
|
151.9 cm
STANDARD_DEVIATION 20.72 • n=99 Participants
|
150.4 cm
STANDARD_DEVIATION 19.31 • n=107 Participants
|
151.1 cm
STANDARD_DEVIATION 19.92 • n=206 Participants
|
|
Weight
|
63.8 kg
STANDARD_DEVIATION 29.99 • n=99 Participants
|
62.6 kg
STANDARD_DEVIATION 30.33 • n=107 Participants
|
63.2 kg
STANDARD_DEVIATION 30.03 • n=206 Participants
|
|
Weight category
>= 20 kg and < 50 kg
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Weight category
>= 50 kg and < 80 kg
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Weight category
>= 80 kg and <= 150 kg
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Body mass index (BMI)
|
26.1 kg/m^2
STANDARD_DEVIATION 7.58 • n=99 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 8.09 • n=107 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 7.81 • n=206 Participants
|
|
BMI category
< 95th percentile
|
49 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
BMI category
>= 95th percentile
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
104.2 mL/min/1.73m^2
STANDARD_DEVIATION 24.86 • n=99 Participants
|
112.1 mL/min/1.73m^2
STANDARD_DEVIATION 19.39 • n=107 Participants
|
108.3 mL/min/1.73m^2
STANDARD_DEVIATION 22.43 • n=206 Participants
|
|
eGFR category
< 60 mL/min/1.73m^2
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
eGFR category
>= 60 and < 90 mL/min/1.73m^2
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
eGFR category
>= 90 mL/min/1.73m^2
|
39 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Enalapril
n=49 Participants
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.
|
Aliskiren
n=50 Participants
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.
|
|---|---|---|
|
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
|
9.22 kg
Standard Error 1.399
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Enalapril
n=49 Participants
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.
|
Aliskiren
n=50 Participants
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.
|
|---|---|---|
|
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
|
7.96 cm
Standard Error 0.607
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Enalapril
n=49 Participants
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.
|
Aliskiren
n=50 Participants
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.
|
|---|---|---|
|
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
|
1.56 kg/m^2
Standard Error 0.502
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Enalapril
n=8 Participants
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.
|
Aliskiren
n=6 Participants
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.
|
|---|---|---|
|
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
|
4 Participants
|
|
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
|
1 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
2 Participants
|
|
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
|
2 Participants
|
|
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
|
1 Participants
|
|
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
|
4 Participants
|
|
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
|
1 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
2 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Enalapril
n=41 Participants
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.
|
Aliskiren
n=44 Participants
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.
|
|---|---|---|
|
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
|
8.33 kg
Standard Error 1.182
|
|
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
|
-3.80 kg
Standard Error 3.445
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Enalapril
n=41 Participants
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.
|
Aliskiren
n=44 Participants
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.
|
|---|---|---|
|
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
|
7.42 cm
Standard Error 0.528
|
|
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
|
16.96 cm
Standard Error 3.044
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Enalapril
n=41 Participants
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.
|
Aliskiren
n=44 Participants
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.
|
|---|---|---|
|
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
|
1.19 kg/m^2
Standard Error 0.424
|
|
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
|
-2.97 kg/m^2
Standard Error 1.397
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Enalapril
n=8 Participants
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.
|
Aliskiren
n=6 Participants
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.
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
5 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
4 Participants
|
|
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
|
1 Participants
|
|
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
|
1 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
4 Participants
|
|
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
|
2 Participants
|
|
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
|
1 Participants
|
|
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
|
3 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
Adverse Events
Enalapril
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Aliskiren
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enalapril
n=51 participants at risk
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.
|
Aliskiren
n=55 participants at risk
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.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Phimosis
|
2.0%
1/51 • Number of events 1 • This study only collected the occurrence of Serious Adverse Events (SAEs) occurring within the first 30 days after the participant had completed the first extension study. SAEs experienced after this 30 day period were reported to Novartis/Noden only if the investigator suspected a causal relationship to the study drug. Every SAE, within the above timeframe was to be reported to Novartis/Noden within 24 hours of learning of its occurrence.
|
0.00%
0/55 • This study only collected the occurrence of Serious Adverse Events (SAEs) occurring within the first 30 days after the participant had completed the first extension study. SAEs experienced after this 30 day period were reported to Novartis/Noden only if the investigator suspected a causal relationship to the study drug. Every SAE, within the above timeframe was to be reported to Novartis/Noden within 24 hours of learning of its occurrence.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contract with new study sponsor "Noden Pharma".
- Publication restrictions are in place
Restriction type: OTHER