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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: Aliskiren 3.125 mini-tablets
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM. Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
Period Title: Overall Study
Started 19 20
Completed 18 19
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             1
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg Total
Hide Arm/Group Description Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM. Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM. Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
12.2  (3.12) 11.8  (3.78) 12.0  (3.44)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
6-11 years old 10 10 20
12-17 years old 9 10 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
10
  52.6%
8
  40.0%
18
  46.2%
Male
9
  47.4%
12
  60.0%
21
  53.8%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients
Hide Description 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.
Time Frame Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description:
Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 1: 6-11 years old, n=10, 10 76.8  (78.21) 393.3  (377.37)
Day 8: 6-11 years old, n=9, 10 82.2  (97.85) 397.1  (187.06)
Day 1: 12-17 years old, n=9, 10 136.5  (132.57) 424.3  (188.79)
Day 8: 12-17 years old, n=9, 10 278.7  (357.54) 485.7  (300.58)
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description:
Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Day 1: 6-11 years old, n=10, 10 278.3  (237.29) 1231.0  (728.46)
Day 8: 6-11 years old, n=9, 10 403.6  (326.76) 1959.9  (821.43)
Day 1: 12-17 years old, n=9, 10 390.9  (264.50) 1808.7  (806.78)
Day 8: 12-17 years old, n=9, 10 847.2  (803.44) 2087.0  (999.10)
3.Primary Outcome
Title Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients
Hide Description 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.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description:
Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: mL/h/kg
Day 8: 6-11 years old, n=9, 10 9694.0  (8704.71) 3905.4  (2628.52)
Day 8: 12-17 years old, n=9, 10 5388.1  (5580.55) 3539.0  (1587.49)
4.Secondary Outcome
Title Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients. Data was not available for all patients at all time points. For each time point, n = the number of subjects for whom data was available for each treatment group.
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description:
Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng/mL/h
Day 1: 2 h post-dose, n=15, 15 -1.8  (1.62) -4.0  (6.68)
Day 1: 10 h post-dose, n=14, 13 -1.8  (1.73) -3.8  (6.79)
Day 8: pre-dose, n=14, 15 -1.3  (1.77) -3.5  (5.91)
Day 8: 2 h post-dose, n=11, 14 -1.4  (1.60) -3.6  (6.79)
Day 8: 10 h post dose, n=13, 15 -1.7  (1.81) -3.8  (6.41)
Day 8-9: 24 h post dose, n=13, 15 -1.5  (1.82) -3.6  (6.46)
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to end of treatment (Day 9)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients.
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description:
Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: mmHg
msSBP: 6-11 years old, n=10, 10 -4.5  (14.63) -7.7  (11.76)
msSBP: 12-17 years old,n=9, 10 -7.6  (9.07) -7.7  (9.38)
msDBP: 6-11 years old, n=10, 10 -1.7  (4.69) 0.0  (8.87)
msDBP: 12-17 years old, n=9, 10 -5.3  (8.78) -5.8  (8.00)
Time Frame 12 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Hide Arm/Group Description Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM. Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
All-Cause Mortality
Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   1/20 (5.00%) 
Infections and infestations     
Swine influenza  1  0/19 (0.00%)  1/20 (5.00%) 
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%
Aliskiren 2 mg/kg Aliskiren 6 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   10/19 (52.63%)   7/20 (35.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/19 (0.00%)  1/20 (5.00%) 
Ear and labyrinth disorders     
Tinnitus  1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/19 (0.00%)  1/20 (5.00%) 
Abdominal pain upper  1  1/19 (5.26%)  2/20 (10.00%) 
Diarrhoea  1  0/19 (0.00%)  1/20 (5.00%) 
Nausea  1  1/19 (5.26%)  2/20 (10.00%) 
General disorders     
Fatigue  1  1/19 (5.26%)  0/20 (0.00%) 
Pyrexia  1  0/19 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Nasopharyngitis  1  1/19 (5.26%)  0/20 (0.00%) 
Upper respiratory tract infection  1  1/19 (5.26%)  0/20 (0.00%) 
Investigations     
Blood pressure increased  1  1/19 (5.26%)  0/20 (0.00%) 
Body temperature increased  1  1/19 (5.26%)  0/20 (0.00%) 
Nervous system disorders     
Headache  1  4/19 (21.05%)  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/19 (5.26%)  1/20 (5.00%) 
Epistaxis  1  1/19 (5.26%)  0/20 (0.00%) 
Pharyngeal inflammation  1  1/19 (5.26%)  0/20 (0.00%) 
Productive cough  1  1/19 (5.26%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  0/19 (0.00%)  1/20 (5.00%) 
Vascular disorders     
Flushing  1  0/19 (0.00%)  1/20 (5.00%) 
Hypertension  1  0/19 (0.00%)  1/20 (5.00%) 
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 single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00834041     History of Changes
Other Study ID Numbers: CSPP100A2256
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: January 18, 2011
Results First Posted: May 9, 2011
Last Update Posted: May 9, 2011