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A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

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ClinicalTrials.gov Identifier: NCT00834041
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE January 30, 2009
First Posted Date  ICMJE February 3, 2009
Results First Submitted Date  ICMJE January 18, 2011
Results First Posted Date  ICMJE May 9, 2011
Last Update Posted Date May 9, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients [ Time Frame: Day 1 and Day 8 ]
    Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
  • Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients [ Time Frame: Day 1 and Day 8 ]
    Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
  • Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients [ Time Frame: Day 8 ]
    Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
Evaluate the Safety and tolerability of aliskiren [ Time Frame: 12 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9 [ Time Frame: Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8-9 ]
    Blood samples (2 mL) for pharmacodynamics evaluation of plasma renin activity were drawn pre-dose and at 2 and 10 hours following the dose of study medication on Day 1 and at pre-dose and at 2, 10, and 24 hours post-dose on Day 8-9.
  • Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients [ Time Frame: Baseline to end of treatment (Day 9) ]
    Blood pressure (BP) measurements were made with a mercury sphygmomanometer or an automated blood pressure measuring device. Sitting BP was measured 3 times at 2-3 minute intervals after the patient had been sitting for 5 minutes. Means of the 3 measurements were calculated. A negative change in BP indicates lowered BP.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
  • Effect of age on pharmacokinetics of aliskiren [ Time Frame: 12 days ]
  • Dose proportionality on exposure to aliskiren [ Time Frame: 12 days ]
  • Relationship between change in PRA and the dose of aliskiren [ Time Frame: 12 days ]
  • Relationship between PRA (change from baseline) and age [ Time Frame: 12 days ]
  • Relationship between change in blood pressure and change in PRA [ Time Frame: 12 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Official Title  ICMJE An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Brief Summary This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Aliskiren 3.125 mini-tablets
Oral mini-tablets (3.125 mg) of aliskiren once each morning
Study Arms  ICMJE
  • Experimental: Aliskiren 2 mg/kg
    Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning
    Intervention: Drug: Aliskiren 3.125 mini-tablets
  • Experimental: Aliskiren 6 mg/kg
    Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning
    Intervention: Drug: Aliskiren 3.125 mini-tablets
Publications * Sullivan JE, Keefe D, Zhou Y, Satlin L, Fang H, Yan JH. Pharmacokinetics, safety profile, and efficacy of aliskiren in pediatric patients with hypertension. Clin Pediatr (Phila). 2013 Jul;52(7):599-607. doi: 10.1177/0009922813483875. Epub 2013 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2010)
39
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2009)
36
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 6-17 years of age
  • Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004)
  • Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization
  • Able to safely wash out previous antihypertensive therapy for 1-2 weeks

Exclusion Criteria:

  • Body weight of < 21 kg (45 lbs) or > 100 kg (220 lbs)
  • Inability to discontinue prior antihypertensive medication as required during the washout period
  • Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
  • Renal artery stenosis
  • Current diagnosis of heart failure (NYHA Class II-IV)
  • msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
  • Second or third degree heart block with or without a pacemaker
  • Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
  • Evidence of current symptomatic valvular disease

Other protocol-defined inclusion/exclusion criteria applied to the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Hungary,   Poland,   United States
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT00834041
Other Study ID Numbers  ICMJE CSPP100A2256
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Novartis
PRS Account Novartis
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP