| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1) | 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. | 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. | Posted | | Mean | Standard Error | millimeter(s) of mercury (mmHg) | | Baseline to endpoint (Week 4 or Last observation carried forward (LOCF)) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. | | OG002 | Phase 1: 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-5.54± 0.78
- OG001-5.42± 1.331
- OG002-9.03± 1.008
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| Primary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2) | 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. | The primary analysis was performed on the FAS population. | Posted | | Mean | Standard Error | mmHg | | Week 4 to endpoint (Week 8 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 2: Aliskiren Low (6.25/12.5/25 mg) | Participants received body-weight 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. | | OG001 | Phase 2: Placebo Low | Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily. | | OG002 | Phase 2: Aliskiren Mid (37.5/75/150 mg) | 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. |
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| Secondary | Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1) | 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. | 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) | Posted | | Number | | participants | | Baseline up to Week 4 | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. |
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| Secondary | Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2) | 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. | 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). | Posted | | Number | | participants | | From Week 4 to Week 8 | | | | ID | Title | Description |
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| OG000 | Phase 2: Aliskiren Low (6.25/12.5/25 mg) | Participants received body-weight 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. | | OG001 | Phase 2: Placebo Low | Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily. | |
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| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1) | 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. | 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. | Posted | | Mean | Standard Error | mmHg | | Baseline to endpoint (Week 4 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. | |
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2) | 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. | 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. | Posted | | Mean | Standard Error | mmHg | | Week 4 to endpoint (Week 8 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 2: Aliskiren Low (6.25/12.5/25 mg) | Participants received body-weight 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. | | OG001 | Phase 2: Placebo Low | Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily. | | OG002 | Phase 2: Aliskiren Mid (37.5/75/150 mg) | |
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| Secondary | Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1) | 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). | 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. | Posted | | Mean | Standard Error | mmHg | | Baseline to endpoint (Week 4 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. | | OG002 | Phase 1: Aliskiren High (150/300/600 mg) |
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| Secondary | Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2) | 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). | 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. | Posted | | Mean | Standard Error | mmHg | | Week 4 to endpoint (Week 8 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 2: Aliskiren Low (6.25/12.5/25 mg) | Participants received body-weight 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. | | OG001 | Phase 2: Placebo Low | Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily. | | OG002 | Phase 2: Aliskiren Mid (37.5/75/150 mg) | 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. |
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| Secondary | Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1) | 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. | 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. | Posted | | Number | | Percentage of participants | | Baseline to endpoint (Week 4 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. | | OG002 | Phase 1: Aliskiren High (150/300/600 mg) | |
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| Secondary | Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1) | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to endpoint (Week 4 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. |
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| Secondary | Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1) | 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. | 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. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to Week 4 | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. |
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| Secondary | Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1) | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to endpoint (Week 4 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. |
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| Secondary | Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1) | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to endpoint (Week 4 or LOCF) | | | | ID | Title | Description |
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| OG000 | Phase 1: Aliskiren Low (6.25/12.5/25 mg) | 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. | | OG001 | Phase 1: Aliskiren Mid (37.5/75/150 mg) | 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. |
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