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

This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01150357
First received: June 23, 2010
Last updated: April 30, 2013
Last verified: April 2013
History of Changes

June 23, 2010
April 30, 2013
June 2010
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01150357 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
Drug: Aliskiren
aliskiren (6.25/12.5/25 mg)
  • Experimental: Mid dose
    aliskiren (37.5/75/150 mg). Patient may also receive placebo as part of phase 2.
    Interventions:
    • Drug: Aliskiren
    • Drug: Aliskiren
    • Drug: Aliskiren
  • Experimental: High dose
    aliskiren (150/300/600 mg). Patient may receive placebo in phase 2.
    Interventions:
    • Drug: Aliskiren
    • Drug: Aliskiren
    • Drug: Aliskiren
  • Experimental: Low Dose Aliskiren
    aliskiren (6.25/12.5/25 mg. Patient may receive placebo as part of phase 2
    Interventions:
    • Drug: Aliskiren
    • Drug: Aliskiren
    • Drug: Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
275
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Belgium,   France,   Germany,   Guatemala,   Hungary,   Poland,   Puerto Rico,   Slovakia,   Turkey
 
NCT01150357
CSPP100A2365, 2009-017028-22
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP