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

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-0006
United States, Arkansas
Novartis Investigative Site
Little Rock, Arkansas, United States, 72202
United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90048
Novartis Investigative Site
San Diego, California, United States, 92123
United States, Florida
Novartis Investigative Site
Pensacola, Florida, United States, 32504
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30322
Novartis Investigative Site
Dalton, Georgia, United States, 30721
United States, Idaho
Novartis Investigative Site
Lewiston, Idaho, United States, 83501
United States, Illinois
Novartis Investigative Site
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40202
United States, Mississippi
Novartis Investigative Site
Hattiesburg, Mississippi, United States, 39401
Novartis Investigative Site
Jackson, Mississippi, United States, 39209
United States, New Jersey
Novartis Investigative Site
Hackensack, New Jersey, United States, 07601
United States, New York
Novartis Investigative Site
New York, New York, United States, 10016
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43205
Novartis Investigative Site
Toledo, Ohio, United States, 43606
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97225
Novartis Investigative Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29425
United States, Texas
Novartis Investigative Site
Amarillo, Texas, United States, 79106
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98105
United States, West Virginia
Novartis Investigative Site
Charleston, West Virginia, United States, 25304
Belgium
Novartis Investigative Site
Brussel, Belgium, 1090
Novartis Investigative Site
Edegem, Belgium, 2650
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Marburg, Germany, 35039
Guatemala
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Hungary
Novartis Investigative Site
Budapest, Hungary, 1083
Novartis Investigative Site
Budapest, Hungary, 1131
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Miskolc, Hungary, 3529
Novartis Investigative Site
Nyiregyhaza, Hungary, 4400
Novartis Investigative Site
Szeged, Hungary, 6725
Novartis Investigative Site
Veszprem, Hungary, H-8200
Poland
Novartis Investigative Site
Warszawa, Poland, 04-154
Puerto Rico
Novartis Investigative Site
San Juan, Puerto Rico, 00907
Slovakia
Novartis Investigative Site
Bratislava, Slovakia, 84103
Novartis Investigative Site
Bratislava, Slovakia, 85107
Novartis Investigative Site
Martin, Slovakia, 03601
Novartis Investigative Site
Myjava, Slovakia, 90701
Novartis Investigative Site
Presov, Slovakia, 08001
Novartis Investigative Site
Trnava, Slovakia, 91701
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06500
Novartis Investigative Site
Ankara, Turkey, 06490
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 September 18, 2014