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Trial record 2 of 7 for:    aliskiren children

Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

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ClinicalTrials.gov Identifier: NCT01150357
Recruitment Status : Completed
First Posted : June 24, 2010
Results First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Aliskiren (6.25/12.5/25 mg)
Drug: Aliskiren (37.5/75/150 mg)
Drug: Aliskiren (150/300/600 mg)
Enrollment 267
Recruitment Details The study was conducted at 51 centers in 8 countries.
Pre-assignment Details 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
Arm/Group Title Aliskiren Low (6.25/12.5/25 mg) Aliskiren Mid (37.5/75/150 mg) Aliskiren High (150/300/600 mg)
Hide Arm/Group Description

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.

During Phase 1: 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.

During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment.

During Phase 1: 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.

During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment.

Period Title: Dose Response Phase (Phase 1)
Started 108 54 105
Completed 107 51 102
Not Completed 1 3 3
Reason Not Completed
Protocol Violation             0             1             1
Unsatisfactory therapeutic effect             1             0             0
Adverse Event             0             0             1
Withdrawal by Participants             0             2             1
Period Title: Placebo-controlled Withdrawal (Phase 2)
Started 107 51 102
Started Aliskiren Treament 50 30 50
Completed Aliskiren Treament 50 30 49
Started Placebo Treatment 57 21 52
Completed Placebo Treament 54 21 51
Completed 104 51 100
Not Completed 3 0 2
Reason Not Completed
Adverse Event             0             0             2
Withdrawal by Subject             2             0             0
Lost to Follow-up             1             0             0
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg) Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 108 54 105 267
Hide Baseline Analysis Population Description
The analysis was performed in the full analysis set population consisted of all participants who were randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 54 participants 105 participants 267 participants
11.9  (3.27) 11.6  (3.29) 11.8  (3.5) 11.8  (3.36)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 54 participants 105 participants 267 participants
Children 6 – 11 years 49 28 51 128
Adolescents 12 – 17 years 59 26 54 139
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 54 participants 105 participants 267 participants
Female
35
  32.4%
17
  31.5%
39
  37.1%
91
  34.1%
Male
73
  67.6%
37
  68.5%
66
  62.9%
176
  65.9%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)
Hide Description 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 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Time Frame Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))
Hide Outcome Measure Data
Hide Analysis Population Description
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 post­baseline assessment for primary efficacy. Here, "Number of participants analyzed" signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 108 53 104
Mean (Standard Error)
Unit of Measure: millimeter(s) of mercury (mmHg)
-5.54  (0.78) -5.42  (1.331) -9.03  (1.008)
2.Primary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)
Hide Description 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 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Time Frame Week 4 to endpoint (Week 8 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was performed on the FAS population.
Arm/Group Title Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Placebo Low Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Placebo Mid Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo High
Hide Arm/Group Description:
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.
Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
Overall Number of Participants Analyzed 50 57 30 21 49 52
Mean (Standard Error)
Unit of Measure: mmHg
-0.53  (0.947) -0.64  (1.256) -2.59  (1.119) -2.9  (1.481) -1.97  (1.071) 1.11  (1.185)
3.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)
Hide Description 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.
Time Frame Baseline up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 108 54 105
Measure Type: Number
Unit of Measure: participants
AEs 30 14 37
SAEs 0 0 1
4.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)
Hide Description 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.
Time Frame From Week 4 to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Placebo Low Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Placebo Mid Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo High
Hide Arm/Group Description:
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.
Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
Overall Number of Participants Analyzed 50 57 30 21 50 52
Measure Type: Number
Unit of Measure: participants
AEs 18 22 10 5 21 17
SAEs 0 0 0 0 2 0
5.Secondary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)
Hide Description 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 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Time Frame Baseline to endpoint (Week 4 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 108 53 104
Mean (Standard Error)
Unit of Measure: mmHg
-2.71  (0.67) -4.05  (1.116) -6.33  (0.793)
6.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)
Hide Description 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 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Time Frame Week 4 to endpoint (Week 8 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Placebo Low Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Placebo Mid Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo High
Hide Arm/Group Description:
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.
Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
Overall Number of Participants Analyzed 50 57 30 21 49 52
Mean (Standard Error)
Unit of Measure: mmHg
1.27  (1.025) -1.08  (1.012) 0.89  (1.502) 1.52  (1.248) 0.37  (1.052) 1.51  (1.009)
7.Secondary Outcome
Title Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)
Hide Description 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*(SBP­DBP).
Time Frame Baseline to endpoint (Week 4 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 108 53 104
Mean (Standard Error)
Unit of Measure: mmHg
-3.65  (0.613) -4.51  (1.064) -7.23  (0.711)
8.Secondary Outcome
Title Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)
Hide Description 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).
Time Frame Week 4 to endpoint (Week 8 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Placebo Low Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Placebo Mid Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo High
Hide Arm/Group Description:
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.
Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
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.
Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
Overall Number of Participants Analyzed 50 57 30 21 49 52
Mean (Standard Error)
Unit of Measure: mmHg
0.67  (0.864) -0.93  (0.964) -0.27  (1.239) 0.05  (1.14) -0.41  (0.885) 1.37  (0.918)
9.Secondary Outcome
Title Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)
Hide Description 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.
Time Frame Baseline to endpoint (Week 4 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 108 53 104
Measure Type: Number
Unit of Measure: Percentage of participants
50.9 58.5 69.2
10.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)
Hide Description Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24­hour 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 24­hour monitoring period for removal of device and BP assessments. The ABPM device was pre­set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 – 24 hours.
Time Frame Baseline to endpoint (Week 4 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 58 29 65
Mean (Standard Deviation)
Unit of Measure: mmHg
MASBP (n=58, 29, 65) -1.6  (6.48) -5.9  (5.8) -5.8  (7.15)
MADBP (n=58, 29, 65) -1.1  (5.33) -4.4  (4.41) -4.9  (6.05)
11.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)
Hide Description ABPM was performed over a 24­hour 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.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 58 29 65
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Day time (n= 58, 29, 65) -2.72  (1.031) -6.76  (1.381) -6.56  (0.95)
Night time (n= 57, 29, 65) -2.55  (1.035) -4.67  (1.381) -4.9  (0.95)
12.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)
Hide Description ABPM was performed over a 24­hour 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.
Time Frame Baseline to endpoint (Week 4 or LOCF)
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Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
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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.
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.
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.
Overall Number of Participants Analyzed 40 21 47
Mean (Standard Deviation)
Unit of Measure: mmHg
MASBP -1.2  (6.18) -4.6  (5.47) -6  (6.19)
MADBP -0.6  (5.78) -3.6  (4.19) -5.3  (5.55)
13.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non-­Dipper Participants at Endpoint (Phase 1)
Hide Description ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non­dippers 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.
Time Frame Baseline to endpoint (Week 4 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 18 8 18
Mean (Standard Deviation)
Unit of Measure: mmHg
MASBP -2.6  (7.21) -9.3  (5.54) -5.2  (9.39)
MADBP -2.3  (4.05) -6.7  (4.45) -5.2  (7.3)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg) Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo Low Phase 2: Placebo Mid Phase 2: Placebo High
Hide Arm/Group Description 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. 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. 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. 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. 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.

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.

Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily. Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily. Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
All-Cause Mortality
Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg) Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo Low Phase 2: Placebo Mid Phase 2: Placebo High
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg) Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo Low Phase 2: Placebo Mid Phase 2: Placebo High
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/54 (0.00%)   1/105 (0.95%)   0/50 (0.00%)   0/30 (0.00%)   2/50 (4.00%)   0/57 (0.00%)   0/21 (0.00%)   0/52 (0.00%) 
Injury, poisoning and procedural complications                   
Head injury  1  0/108 (0.00%)  0/54 (0.00%)  1/105 (0.95%)  0/50 (0.00%)  0/30 (0.00%)  0/50 (0.00%)  0/57 (0.00%)  0/21 (0.00%)  0/52 (0.00%) 
Nervous system disorders                   
Syncope  1  0/108 (0.00%)  0/54 (0.00%)  0/105 (0.00%)  0/50 (0.00%)  0/30 (0.00%)  1/50 (2.00%)  0/57 (0.00%)  0/21 (0.00%)  0/52 (0.00%) 
Psychiatric disorders                   
Suicide attempt  1  0/108 (0.00%)  0/54 (0.00%)  0/105 (0.00%)  0/50 (0.00%)  0/30 (0.00%)  1/50 (2.00%)  0/57 (0.00%)  0/21 (0.00%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1: Aliskiren Low (6.25/12.5/25 mg) Phase 1: Aliskiren Mid (37.5/75/150 mg) Phase 1: Aliskiren High (150/300/600 mg) Phase 2: Aliskiren Low (6.25/12.5/25 mg) Phase 2: Aliskiren Mid (37.5/75/150 mg) Phase 2: Aliskiren High (150/300/600 mg) Phase 2: Placebo Low Phase 2: Placebo Mid Phase 2: Placebo High
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/108 (10.19%)   6/54 (11.11%)   14/105 (13.33%)   8/50 (16.00%)   7/30 (23.33%)   9/50 (18.00%)   7/57 (12.28%)   3/21 (14.29%)   5/52 (9.62%) 
Gastrointestinal disorders                   
Diarrhoea  1  3/108 (2.78%)  3/54 (5.56%)  2/105 (1.90%)  0/50 (0.00%)  0/30 (0.00%)  0/50 (0.00%)  0/57 (0.00%)  1/21 (4.76%)  0/52 (0.00%) 
Infections and infestations                   
Acute tonsillitis  1  0/108 (0.00%)  0/54 (0.00%)  0/105 (0.00%)  0/50 (0.00%)  2/30 (6.67%)  0/50 (0.00%)  0/57 (0.00%)  0/21 (0.00%)  0/52 (0.00%) 
Upper respiratory tract infection  1  3/108 (2.78%)  3/54 (5.56%)  5/105 (4.76%)  3/50 (6.00%)  3/30 (10.00%)  4/50 (8.00%)  2/57 (3.51%)  1/21 (4.76%)  2/52 (3.85%) 
Nervous system disorders                   
Headache  1  5/108 (4.63%)  3/54 (5.56%)  7/105 (6.67%)  4/50 (8.00%)  1/30 (3.33%)  4/50 (8.00%)  3/57 (5.26%)  2/21 (9.52%)  3/52 (5.77%) 
Respiratory, thoracic and mediastinal disorders                   
Oropharyngeal pain  1  1/108 (0.93%)  0/54 (0.00%)  1/105 (0.95%)  1/50 (2.00%)  2/30 (6.67%)  2/50 (4.00%)  3/57 (5.26%)  0/21 (0.00%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 single­site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 ­778 ­8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01150357     History of Changes
Other Study ID Numbers: CSPP100A2365
2009-017028-22 ( EudraCT Number )
First Submitted: June 23, 2010
First Posted: June 24, 2010
Results First Submitted: August 10, 2015
Results First Posted: October 15, 2015
Last Update Posted: October 15, 2015