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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Aliskiren 3.125 mini-tablets | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Aliskiren 2 mg/kg
Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning
|
Drug: Aliskiren 3.125 mini-tablets
Oral mini-tablets (3.125 mg) of aliskiren once each morning
|
Experimental: Aliskiren 6 mg/kg
Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning
|
Drug: Aliskiren 3.125 mini-tablets
Oral mini-tablets (3.125 mg) of aliskiren once each morning
|
- 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.
- 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.

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834041
United States, Kentucky | |
Investigative Site | |
Louisville, Kentucky, United States | |
Belgium | |
Investigative Site | |
Brussels, Belgium | |
Brazil | |
Investigative Site | |
Brasilia, Brazil | |
Hungary | |
Investigative Site | |
Budapest, Hungary | |
Poland | |
Investigative Site | |
Warsaw, Poland |
Study Chair: | Novartis | Novartis |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | External Affairs, Novartis |
ClinicalTrials.gov Identifier: | NCT00834041 History of Changes |
Other Study ID Numbers: |
CSPP100A2256 |
First Posted: | February 3, 2009 Key Record Dates |
Results First Posted: | May 9, 2011 |
Last Update Posted: | May 9, 2011 |
Last Verified: | April 2011 |
Keywords provided by Novartis:
aliskiren pediatric hypertension pharmacokinetics (PK) |
pharmacodynamics (PD) plasma renin activity mini-tablet formulation |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases |