Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
NCT ID: NCT01150357
Last Updated: 2015-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
267 participants
INTERVENTIONAL
2010-06-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low Dose Aliskiren
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
Aliskiren (6.25/12.5/25 mg)
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.
Mid dose
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
Aliskiren (37.5/75/150 mg)
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
High dose
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
Aliskiren (150/300/600 mg)
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
Interventions
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Aliskiren (6.25/12.5/25 mg)
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.
Aliskiren (37.5/75/150 mg)
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
Aliskiren (150/300/600 mg)
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
San Diego, California, United States
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Pensacola, Florida, United States
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Atlanta, Georgia, United States
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Dalton, Georgia, United States
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Lewiston, Idaho, United States
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Park Ridge, Illinois, United States
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Louisville, Kentucky, United States
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Hattiesburg, Mississippi, United States
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Jackson, Mississippi, United States
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Hackensack, New Jersey, United States
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New York, New York, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Amarillo, Texas, United States
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Seattle, Washington, United States
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Charleston, West Virginia, United States
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Marburg, , Germany
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Guatemala City, Departamento de Guatemala, Guatemala
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Nyíregyháza, Hungary, Hungary
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Szeged, Hungary, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Miskolc, , Hungary
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Veszprém, , Hungary
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Warsaw, , Poland
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San Juan, , Puerto Rico
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Bratislava, Slovakia, Slovakia
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Bratislava, Slovakia, Slovakia
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Martin, Slovakia, Slovakia
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Myjava, Slovakia, Slovakia
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Prešov, Slovakia, Slovakia
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Trnava, Slovakia, Slovakia
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Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2009-017028-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSPP100A2365
Identifier Type: -
Identifier Source: org_study_id
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