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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00834041

Purpose

This first open-label study in a pediatric population is designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6

17 year old children (includes children 6 to less than 18 years of age) with hypertension. The study includes doses (2 mg/kg and 6 mg/kg) that span the dose range researched in adults. The total dose of aliskiren will be calculated based on body weight (maximum 100 kg for inclusion) and will be no greater than 600 mg.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Low Dose Drug: Aliskiren High Dose	Phase I Phase II

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	An 8-Day Open-Label, Multiple-Dose, Multi-Center Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6 - 17 Years of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

Evaluate the Safety and tolerability of aliskiren [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect of age on pharmacokinetics of aliskiren [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Dose proportionality on exposure to aliskiren [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Relationship between change in PRA and the dose of aliskiren [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Relationship between PRA (change from baseline) and age [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Relationship between change in blood pressure and change in PRA [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	February 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Aliskiren 2 mg/kg body weight	Drug: Aliskiren Low Dose Aliskiren 2 mg/kg body weight
2: Active Comparator Aliskiren 6 mg/kg body weight	Drug: Aliskiren High Dose Aliskiren 6 mg/kg body weight

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, 6 - 17 years of age (6 to less than 18 years of age at study completion)
Documented history of hypertension
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
Evidence of current symptomatic valvular disease

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834041

Contacts

Contact: Novartis

862-778-8300

Locations

United States, Florida
Investigative Site
Daytona Beach, Florida, United States
Belgium
Investigative Site
Brussels, Belgium
Brazil
Investigative Site
Brasilia, Brazil
Hungary
Investigative Site
Budapest, Hungary
Poland
Investigative Site
Warsaw, Poland
Turkey
Investigative Site
Ankara, Turkey

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2256
Study First Received:	January 30, 2009
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00834041 History of Changes
Health Authority:	United States: Food and Drug Administration; Hungary: National Institute of Pharmacy; Brazil: Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Turkey: Ministry of Health

Keywords provided by Novartis:

Aliskiren
pediatric
hypertension
pharmacokinetics (PK)

pharmacodynamics (PD)
PRA
mini-tablet formulation

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009