Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age - Full Text View

Purpose

This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

In Phase 1 (dose response phase), change in msSBP from the baseline to end of phase 1. In Phase 2 (placebo controlled phase), change in msSBP from at end of Phase 1 to the end of Phase 2 Time Frame: Phase 1, 4 weeks, Phase 2, 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of Phase 1 Time Frame: 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in msDBP from end of Phase 1 to end of phase [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Calculated mean arterial pressure (MAP) change from baseline to end of Phase 1 Time Frame [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Calculate MAP change from end of Phase 1 to end of Phase 2 Time Frame [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To explore the effect of aliskiren at low, mid and high doses on the 24 hour ambulatory blood pressure monitoring (ABPM) profiles. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	275
Study Start Date:	June 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mid dose aliskiren (37.5/75/150 mg). Patient may also receive placebo as part of phase 2.	Drug: Aliskiren aliskiren (6.25/12.5/25 mg) Drug: Aliskiren aliskiren (6.25/12.5/25 mg) Drug: Aliskiren aliskiren (6.25/12.5/25 mg)
Experimental: High dose aliskiren (150/300/600 mg). Patient may receive placebo in phase 2.	Drug: Aliskiren aliskiren (6.25/12.5/25 mg) Drug: Aliskiren aliskiren (6.25/12.5/25 mg) Drug: Aliskiren aliskiren (6.25/12.5/25 mg)
Experimental: Low Dose Aliskiren aliskiren (6.25/12.5/25 mg. Patient may receive placebo as part of phase 2	Drug: Aliskiren aliskiren (6.25/12.5/25 mg) Drug: Aliskiren aliskiren (6.25/12.5/25 mg) Drug: Aliskiren aliskiren (6.25/12.5/25 mg)

Eligibility

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

Criteria

Inclusion Criteria:

Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004

Exclusion Criteria:

Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
msSBP ≥ 25% above the 95th percentile
Second or third degree heart block without a pacemaker
AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
Total bilirubin > 2 times the upper limit of the reference range
Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
WBC count < 3000/mm³

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150357

Contacts

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Show 89 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01150357 History of Changes
Other Study ID Numbers:	CSPP100A2365, 2009-017028-22
Study First Received:	June 23, 2010
Last Updated:	April 30, 2013
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Germany: Federal Institute for Drugs and Medical Devices Slovakia: State Institute for Drug Control Turkey: General Directorate of Pharmaceuticals and Pharmacy Hungary: National Institute of Pharmacy Poland: The Central Register of Clinical Trials France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:

Pediatric hypertension
primary hypertension
secondary hypertension

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013