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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

Brief 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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1) [ Time Frame: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF)) ]
    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.
  • Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2) [ Time Frame: Week 4 to endpoint (Week 8 or LOCF) ]
    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.


Original Primary Outcome: In Phase 1 (dose response phase), change in msSBP from the baseline to end of phase 1. In Phase 2 (placebo controlled phase), change in msSBP from at end of Phase 1 to the end of Phase 2 Time Frame: Phase 1, 4 weeks, Phase 2, 4 weeks [ Time Frame: 4 weeks ]

Current Secondary Outcome:

  • Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1) [ Time Frame: Baseline up 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.
  • Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2) [ Time Frame: From 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.
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1) [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]
    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.
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2) [ Time Frame: Week 4 to endpoint (Week 8 or LOCF) ]
    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.
  • Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1) [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]
    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).
  • Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2) [ Time Frame: Week 4 to endpoint (Week 8 or LOCF) ]
    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).
  • Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1) [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]
    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.
  • Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1) [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]
    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.
  • Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1) [ Time Frame: Baseline to Week 4 ]
    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.
  • Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1) [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]
    ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as pe

    Original Secondary Outcome:

    • Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of Phase 1 Time Frame: 4 weeks [ Time Frame: 4 weeks ]
    • Change in msDBP from end of Phase 1 to end of phase [ Time Frame: 4 weeks ]
    • Calculated mean arterial pressure (MAP) change from baseline to end of Phase 1 Time Frame [ Time Frame: 4 weeks ]
    • Calculate MAP change from end of Phase 1 to end of Phase 2 Time Frame [ Time Frame: 4 weeks ]
    • To explore the effect of aliskiren at low, mid and high doses on the 24 hour ambulatory blood pressure monitoring (ABPM) profiles. [ Time Frame: 8 weeks ]


    Information By: Novartis

    Dates:
    Date Received: June 23, 2010
    Date Started: June 2010
    Date Completion:
    Last Updated: September 15, 2015
    Last Verified: September 2015