Trial Outcomes & Findings for Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age (NCT NCT01150357)
NCT ID: NCT01150357
Last Updated: 2015-10-15
Results Overview
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
267 participants
Primary outcome timeframe
Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))
Results posted on
2015-10-15
Participant Flow
The study was conducted at 51 centers in 8 countries.
A total of 334 participants were screened and placed in screening phase of single blind placebo washout period for up to a maximum of three weeks. Out of 334, 268 participants were randomized in Phase 1 including 1 mis-randomized participants who did not receive any medication. Therefore total of 267 was enrolled in this study
Participant milestones
| Measure |
Aliskiren Low (6.25/12.5/25 mg)
During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment.
|
Aliskiren Mid (37.5/75/150 mg)
During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment.
|
Aliskiren High (150/300/600 mg)
During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment.
|
|---|---|---|---|
|
Dose Response Phase (Phase 1)
STARTED
|
108
|
54
|
105
|
|
Dose Response Phase (Phase 1)
COMPLETED
|
107
|
51
|
102
|
|
Dose Response Phase (Phase 1)
NOT COMPLETED
|
1
|
3
|
3
|
|
Placebo-controlled Withdrawal (Phase 2)
STARTED
|
107
|
51
|
102
|
|
Placebo-controlled Withdrawal (Phase 2)
Started Aliskiren Treament
|
50
|
30
|
50
|
|
Placebo-controlled Withdrawal (Phase 2)
Completed Aliskiren Treament
|
50
|
30
|
49
|
|
Placebo-controlled Withdrawal (Phase 2)
Started Placebo Treatment
|
57
|
21
|
52
|
|
Placebo-controlled Withdrawal (Phase 2)
Completed Placebo Treament
|
54
|
21
|
51
|
|
Placebo-controlled Withdrawal (Phase 2)
COMPLETED
|
104
|
51
|
100
|
|
Placebo-controlled Withdrawal (Phase 2)
NOT COMPLETED
|
3
|
0
|
2
|
Reasons for withdrawal
| Measure |
Aliskiren Low (6.25/12.5/25 mg)
During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment.
|
Aliskiren Mid (37.5/75/150 mg)
During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment.
|
Aliskiren High (150/300/600 mg)
During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment.
|
|---|---|---|---|
|
Dose Response Phase (Phase 1)
Protocol Violation
|
0
|
1
|
1
|
|
Dose Response Phase (Phase 1)
Unsatisfactory therapeutic effect
|
1
|
0
|
0
|
|
Dose Response Phase (Phase 1)
Adverse Event
|
0
|
0
|
1
|
|
Dose Response Phase (Phase 1)
Withdrawal by Participants
|
0
|
2
|
1
|
|
Placebo-controlled Withdrawal (Phase 2)
Adverse Event
|
0
|
0
|
2
|
|
Placebo-controlled Withdrawal (Phase 2)
Withdrawal by Subject
|
2
|
0
|
0
|
|
Placebo-controlled Withdrawal (Phase 2)
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Baseline characteristics by cohort
| Measure |
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (\< ) 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
|
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=54 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=105 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 3.27 • n=5 Participants
|
11.6 years
STANDARD_DEVIATION 3.29 • n=7 Participants
|
11.8 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
11.8 years
STANDARD_DEVIATION 3.36 • n=4 Participants
|
|
Age, Customized
Children 6 - 11 years
|
49 participants
n=5 Participants
|
28 participants
n=7 Participants
|
51 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
Age, Customized
Adolescents 12 - 17 years
|
59 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
139 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))Population: The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy. Here, "Number of participants analyzed" signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=53 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=104 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)
|
-5.42 millimeter(s) of mercury (mmHg)
Standard Error 1.331
|
-9.03 millimeter(s) of mercury (mmHg)
Standard Error 1.008
|
-5.54 millimeter(s) of mercury (mmHg)
Standard Error 0.78
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4 to endpoint (Week 8 or LOCF)Population: The primary analysis was performed on the FAS population.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=57 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=30 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=50 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
n=21 Participants
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
n=49 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
n=52 Participants
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)
|
-0.64 mmHg
Standard Error 1.256
|
-2.59 mmHg
Standard Error 1.119
|
-0.53 mmHg
Standard Error 0.947
|
-2.9 mmHg
Standard Error 1.481
|
-1.97 mmHg
Standard Error 1.071
|
1.11 mmHg
Standard Error 1.185
|
SECONDARY outcome
Timeframe: Baseline up to Week 4Population: The analysis was performed on the Safety Sets (SAF), SAF is all participants who received at least one dose of study treatment during phase 1 (baseline to week 4)
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=54 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=105 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)
AEs
|
14 participants
|
37 participants
|
30 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)
SAEs
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 4 to Week 8Population: The analysis was performed on the SAF which included all participants who received at least one dose of study treatment during phase 2 (week 4 to week 8).
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=57 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=30 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=50 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
n=21 Participants
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
n=50 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
n=52 Participants
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)
AEs
|
22 participants
|
10 participants
|
18 participants
|
5 participants
|
21 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline to endpoint (Week 4 or LOCF)Population: The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for msDBP at Week 4 or LOCF for each arm, respectively.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=53 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=104 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)
|
-4.05 mmHg
Standard Error 1.116
|
-6.33 mmHg
Standard Error 0.793
|
-2.71 mmHg
Standard Error 0.67
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 to endpoint (Week 8 or LOCF)Population: The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for msDBP at Week 8 or LOCF for each arm, respectively.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=57 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=30 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=50 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
n=21 Participants
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
n=49 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
n=52 Participants
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)
|
-1.08 mmHg
Standard Error 1.012
|
0.89 mmHg
Standard Error 1.502
|
1.27 mmHg
Standard Error 1.025
|
1.52 mmHg
Standard Error 1.248
|
0.37 mmHg
Standard Error 1.052
|
1.51 mmHg
Standard Error 1.009
|
SECONDARY outcome
Timeframe: Baseline to endpoint (Week 4 or LOCF)Population: The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for MAP at Week 4 (or LOCF) for each arm, respectively.
MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3\*(SBP-DBP).
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=53 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=104 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)
|
-4.51 mmHg
Standard Error 1.064
|
-7.23 mmHg
Standard Error 0.711
|
-3.65 mmHg
Standard Error 0.613
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 to endpoint (Week 8 or LOCF)Population: The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3\*(SBP-DBP).
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=57 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=30 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=50 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
n=21 Participants
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
n=49 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
n=52 Participants
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)
|
-0.93 mmHg
Standard Error 0.964
|
-0.27 mmHg
Standard Error 1.239
|
0.67 mmHg
Standard Error 0.864
|
0.05 mmHg
Standard Error 1.14
|
-0.41 mmHg
Standard Error 0.885
|
1.37 mmHg
Standard Error 0.918
|
SECONDARY outcome
Timeframe: Baseline to endpoint (Week 4 or LOCF)Population: The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively.
Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=53 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=104 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)
|
58.5 Percentage of participants
|
69.2 Percentage of participants
|
50.9 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to endpoint (Week 4 or LOCF)Population: Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here 'Number of participants analyzed' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24-hour monitoring period for removal of device and BP assessments. The ABPM device was pre-set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 - 24 hours.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=29 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=65 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=58 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)
MASBP (n=58, 29, 65)
|
-5.9 mmHg
Standard Deviation 5.8
|
-5.8 mmHg
Standard Deviation 7.15
|
-1.6 mmHg
Standard Deviation 6.48
|
—
|
—
|
—
|
|
Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)
MADBP (n=58, 29, 65)
|
-4.4 mmHg
Standard Deviation 4.41
|
-4.9 mmHg
Standard Deviation 6.05
|
-1.1 mmHg
Standard Deviation 5.33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=29 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=65 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=58 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)
Day time (n= 58, 29, 65)
|
-6.76 mmHg
Standard Error 1.381
|
-6.56 mmHg
Standard Error 0.95
|
-2.72 mmHg
Standard Error 1.031
|
—
|
—
|
—
|
|
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)
Night time (n= 57, 29, 65)
|
-4.67 mmHg
Standard Error 1.381
|
-4.9 mmHg
Standard Error 0.95
|
-2.55 mmHg
Standard Error 1.035
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to endpoint (Week 4 or LOCF)Population: Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, "Number of participants analyzed" signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively.
ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm - 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am -6pm) ABPM.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=21 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=47 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=40 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)
MASBP
|
-4.6 mmHg
Standard Deviation 5.47
|
-6 mmHg
Standard Deviation 6.19
|
-1.2 mmHg
Standard Deviation 6.18
|
—
|
—
|
—
|
|
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)
MADBP
|
-3.6 mmHg
Standard Deviation 4.19
|
-5.3 mmHg
Standard Deviation 5.55
|
-0.6 mmHg
Standard Deviation 5.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to endpoint (Week 4 or LOCF)Population: Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, "Number of participants analyzed" signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively.
ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non-dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.
Outcome measures
| Measure |
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=8 Participants
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=18 Participants
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=18 Participants
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Placebo Mid
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
|
Phase 2: Aliskiren High (150/300/600 mg)
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo High
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)
MASBP
|
-9.3 mmHg
Standard Deviation 5.54
|
-5.2 mmHg
Standard Deviation 9.39
|
-2.6 mmHg
Standard Deviation 7.21
|
—
|
—
|
—
|
|
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)
MADBP
|
-6.7 mmHg
Standard Deviation 4.45
|
-5.2 mmHg
Standard Deviation 7.3
|
-2.3 mmHg
Standard Deviation 4.05
|
—
|
—
|
—
|
Adverse Events
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 1: Aliskiren Mid (37.5/75/150 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: Aliskiren High (150/300/600 mg)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Phase 2: Aliskiren Low (6.25/12.5/25 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 2: Aliskiren Mid (37.5/75/150 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: Aliskiren High (150/300/600 mg)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 2: Placebo Low
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: Placebo Mid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2: Placebo High
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=54 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=105 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Aliskiren Low (6.25/12.5/25 mg)
n=50 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Aliskiren Mid (37.5/75/150 mg)
n=30 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 2: Aliskiren High (150/300/600 mg)
n=50 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and
≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo Low
n=57 participants at risk
Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
|
Phase 2: Placebo Mid
n=21 participants at risk
Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
|
Phase 2: Placebo High
n=52 participants at risk
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.95%
1/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
|
Nervous system disorders
Syncope
|
0.00%
0/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
2.0%
1/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
2.0%
1/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
Other adverse events
| Measure |
Phase 1: Aliskiren Low (6.25/12.5/25 mg)
n=108 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 1: Aliskiren Mid (37.5/75/150 mg)
n=54 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 1: Aliskiren High (150/300/600 mg)
n=105 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Aliskiren Low (6.25/12.5/25 mg)
n=50 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
|
Phase 2: Aliskiren Mid (37.5/75/150 mg)
n=30 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
|
Phase 2: Aliskiren High (150/300/600 mg)
n=50 participants at risk
Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and
≤ 150 kg received 600 mg of aliskiren.
|
Phase 2: Placebo Low
n=57 participants at risk
Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
|
Phase 2: Placebo Mid
n=21 participants at risk
Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
|
Phase 2: Placebo High
n=52 participants at risk
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
5.6%
3/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
1.9%
2/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
4.8%
1/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
6.7%
2/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
3/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
5.6%
3/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
4.8%
5/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
6.0%
3/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
10.0%
3/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
8.0%
4/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
3.5%
2/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
4.8%
1/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
3.8%
2/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
|
Nervous system disorders
Headache
|
4.6%
5/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
5.6%
3/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
6.7%
7/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
8.0%
4/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
3.3%
1/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
8.0%
4/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
5.3%
3/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
9.5%
2/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
5.8%
3/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.93%
1/108 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/54 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.95%
1/105 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
2.0%
1/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
6.7%
2/30 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
4.0%
2/50 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
5.3%
3/57 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/21 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
0.00%
0/52 • Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 -778 -8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER