An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01151410
First received: June 23, 2010
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Drug: Enalapril
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, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluate the safety and tolerability (by measuring vital signs, AE, SAEs and safety laboratories) of long term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean sitting systolic blood pressure reduction of long-term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy as assessed by calculated mean arterial pressure (MAP), of long-term administration of aliskiren compared to enalapril in hypertensive children 6 to 17 years old [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean sitting diastolic blood pressure reduction of long-term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enalapril

Patients will receive one of the following doses based on the their weight:

Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg

Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg

High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg

Drug: Enalapril

Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg

Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg

High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg

Experimental: Aliskiren

Patients will receive one of the following doses based on the their weight:

Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg

Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg

High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg

Drug: Aliskiren

Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg

Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg

High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg


  Eligibility

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

Inclusion Criteria:

  • msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
  • Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
  • Must be able to swallow minitablets (2mm in diameter) administered in soft food
  • Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

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
  • Platelet count < 100,000/mm³
  • Serum potassium > 5.2 mEq/L
  • 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: NCT01151410

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

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site Recruiting
Birmingham, Alabama, United States, 35294-0006
United States, Arkansas
Novartis Investigative Site Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Novartis Investigative Site Withdrawn
Anaheim, California, United States, 92805
Novartis Investigative Site Completed
Los Angeles, California, United States, 90048
Novartis Investigative Site Recruiting
San Diego, California, United States, 92123
United States, Connecticut
Novartis Investigative Site Withdrawn
Hartford, Connecticut, United States, 06106
United States, Florida
Novartis Investigative Site Withdrawn
Miami, Florida, United States, 33125
Novartis Investigative Site Withdrawn
Miami, Florida, United States, 33136
Novartis Investigative Site Withdrawn
Miami, Florida, United States, 33155
Novartis Investigative Site Not yet recruiting
Pensacola, Florida, United States, 32504
United States, Georgia
Novartis Investigative Site Not yet recruiting
Atlanta, Georgia, United States, 30322
Novartis Investigative Site Withdrawn
Augusta, Georgia, United States, 30909
Novartis Investigative Site Recruiting
Dalton, Georgia, United States, 30721
United States, Hawaii
Novartis Investigative Site Completed
Honolulu, Hawaii, United States, 96813
United States, Idaho
Novartis Investigative Site Completed
Lewiston, Idaho, United States, 83501
United States, Illinois
Novartis Investigative Site Completed
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Novartis Investigative Site Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Novartis Investigative Site Withdrawn
Boston, Massachusetts, United States, 02115
United States, Mississippi
Novartis Investigative Site Completed
Hattiesburg, Mississippi, United States, 39401
Novartis Investigative Site Withdrawn
Jackson, Mississippi, United States, 39216-9941
Novartis Investigative Site Completed
Jackson, Mississippi, United States, 39209
United States, Nebraska
Novartis Investigative Site Withdrawn
Omaha, Nebraska, United States, 68198-3020
United States, New Jersey
Novartis Investigative Site Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Novartis Investigative Site Withdrawn
New Hyde Park, New York, United States, 11040
Novartis Investigative Site Recruiting
New York, New York, United States, 10016
United States, Ohio
Novartis Investigative Site Withdrawn
Cincinnati, Ohio, United States, 45229-3039
Novartis Investigative Site Withdrawn
Cleveland, Ohio, United States, 44106
Novartis Investigative Site Completed
Columbus, Ohio, United States, 43205
Novartis Investigative Site Recruiting
Toledo, Ohio, United States, 43606
United States, Oregon
Novartis Investigative Site Completed
Portland, Oregon, United States, 97225
Novartis Investigative Site Completed
Portland, Oregon, United States, 07227
United States, Pennsylvania
Novartis Investigative Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Novartis Investigative Site Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Novartis Investigative Site Withdrawn
Memphis, Tennessee, United States, 38103
United States, Texas
Novartis Investigative Site Recruiting
Amarillo, Texas, United States, 79106
Novartis Investigative Site Withdrawn
Dallas, Texas, United States, 75235
Novartis Investigative Site Withdrawn
Houston, Texas, United States, 77030
Novartis Investigative Site Withdrawn
Houston, Texas, United States, 77021
Novartis Investigative Site Withdrawn
San Antonio, Texas, United States, 78229-4801
United States, Virginia
Novartis Investigative Site Not yet recruiting
Charlottesville, Virginia, United States, 22908
Novartis Investigative Site Withdrawn
Norfolk, Virginia, United States, 23507
United States, Washington
Novartis Investigative Site Withdrawn
Seattle, Washington, United States, 98105
United States, West Virginia
Novartis Investigative Site Active, not recruiting
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Novartis Investigative Site Withdrawn
Madison, Wisconsin, United States, 53792
Novartis Investigative Site Withdrawn
Milwaukee, Wisconsin, United States, 53226
Belgium
Novartis Investigative Site Recruiting
Brussel, Belgium, 1090
Novartis Investigative Site Not yet recruiting
Edegem, Belgium, 2650
Novartis Investigative Site Not yet recruiting
Gent, Belgium, 9000
Novartis Investigative Site Not yet recruiting
Laeken, Belgium, 1020
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Germany
Novartis Investigative Site Not yet recruiting
Dortmund, Germany, 44137
Novartis Investigative Site Not yet recruiting
Erlangen, Germany, 91054
Novartis Investigative Site Not yet recruiting
Göttingen, Germany, D-37075
Novartis Investigative Site Not yet recruiting
Göttingen, Germany, 37073
Novartis Investigative Site Completed
Hamburg, Germany, 20246
Novartis Investigative Site Not yet recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Marburg, Germany, 35039
Novartis Investigative Site Withdrawn
Muenchen, Germany, 81377
Guatemala
Novartis Investigative Site Recruiting
Guatemala City, Guatemala, 01010
Hungary
Novartis Investigative Site Completed
Budapest, Hungary, 1083
Novartis Investigative Site Withdrawn
Budapest, Hungary, 1094
Novartis Investigative Site Completed
Budapest, Hungary, 1131
Novartis Investigative Site Completed
Debrecen, Hungary, 4032
Novartis Investigative Site Active, not recruiting
Miskolc, Hungary, 3529
Novartis Investigative Site Completed
Nyiregyhaza, Hungary, 4400
Novartis Investigative Site Active, not recruiting
Szeged, Hungary, 6725
Novartis Investigative Site Completed
Veszprem, Hungary, H-8200
Poland
Novartis Investigative Site Withdrawn
Gdansk, Poland, 80-952
Novartis Investigative Site Withdrawn
Krakow, Poland, 30-663
Novartis Investigative Site Withdrawn
Poznan, Poland, 60-572
Novartis Investigative Site Completed
Warszawa, Poland, 04-154
Novartis Investigative Site Withdrawn
Warszawa, Poland, 04-730
Puerto Rico
Novartis Investigative Site Recruiting
San Juan, Puerto Rico, 00907
Slovakia
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 85107
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 84103
Novartis Investigative Site Recruiting
Martin, Slovakia, 03601
Novartis Investigative Site Recruiting
Myjava, Slovakia, 90701
Novartis Investigative Site Recruiting
Presov, Slovakia, 08001
Novartis Investigative Site Recruiting
Trnava, Slovakia, 91701
Turkey
Novartis Investigative Site Withdrawn
Ankara, Turkey, 06100
Novartis Investigative Site Recruiting
Ankara, Turkey, 06100
Novartis Investigative Site Recruiting
Ankara, Turkey, 06490
Novartis Investigative Site Recruiting
Ankara, Turkey, 06500
Novartis Investigative Site Not yet recruiting
Izmir, Turkey, 35340
Novartis Investigative Site Not yet recruiting
Konak/Izmir, Turkey, 35210
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: NCT01151410     History of Changes
Other Study ID Numbers: CSPP100A2365E1, 2009-017029-20
Study First Received: June 23, 2010
Last Updated: July 18, 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
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014