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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
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00834041
First received: January 30, 2009
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Aliskiren 3.125 mini-tablets | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 39 |
| Study Start Date: | April 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00834041
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834041
Locations
| 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 | |
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Novartis | Novartis |
More Information
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 |
| Study First Received: | January 30, 2009 |
| Results First Received: | January 18, 2011 |
| Last Updated: | April 15, 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 |
ClinicalTrials.gov processed this record on June 23, 2017