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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01150357
First received: June 23, 2010
Last updated: August 25, 2014
Last verified: August 2014
  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:


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 ]

Enrollment: 264
Study Start Date: June 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 47 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals 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: August 25, 2014
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 August 28, 2014