Phase 3
Completed N=267
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Source: ClinicalTrials.gov NCT01150357 ↗Enrolled (actual)
267
Serious AEs
0.6%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1) — -5.54; -5.42; -9.03 millimeter(s) of mercury (mmHg)
Summary
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1) |
-5.54; -5.42; -9.03 | — |
| PRIMARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2) |
-0.53; -0.64; -2.59; -2.9; -1.97; 1.11 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1) |
30; 14; 37; 0; 0; 1 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2) |
18; 22; 10; 5; 21; 17 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1) |
-2.71; -4.05; -6.33 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2) |
1.27; -1.08; 0.89; 1.52; 0.37; 1.51 | — |
| SECONDARY Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1) |
-3.65; -4.51; -7.23 | — |
| SECONDARY Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2) |
0.67; -0.93; -0.27; 0.05; -0.41; 1.37 | — |
| SECONDARY Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1) |
50.9; 58.5; 69.2 | — |
| SECONDARY Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1) |
-1.6; -5.9; -5.8; -1.1; -4.4; -4.9 | — |
| SECONDARY Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1) |
-2.72; -6.76; -6.56; -2.55; -4.67; -4.9 | — |
| SECONDARY Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1) |
-1.2; -4.6; -6; -0.6; -3.6; -5.3 | — |
| SECONDARY Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1) |
-2.6; -9.3; -5.2; -2.3; -6.7; -5.2 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
- msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004
Exclusion Criteria
- Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
- Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
- msSBP ≥ 25% above the 95th percentile
- Second or third degree heart block without a pacemaker
- AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
- Total bilirubin > 2 times the upper limit of the reference range
- Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
- WBC count < 3000/mm³
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01150357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.