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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Aliskiren 3.125 mini-tablets (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients

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

Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients

Secondary outcome:

Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 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

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Investigative Site, Brussels, Belgium

Investigative Site, Brasilia, Brazil

Investigative Site, Budapest, Hungary

Investigative Site, Warsaw, Poland

Investigative Site, Louisville, Kentucky, United States

Additional Information

Starting date: April 2009
Last updated: April 15, 2011

Page last updated: August 23, 2015

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