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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01151410
First received: June 23, 2010
Last updated: February 8, 2016
Last verified: January 2016
  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:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study [ Time Frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.


Secondary Outcome Measures:
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study [ Time Frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.

  • Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study [ Time Frame: Baseline to end of study (Week 52 or LOCF) ] [ Designated as safety issue: No ]
    MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP).


Enrollment: 208
Study Start Date: August 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) 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

Active Comparator: Enalapril
Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) 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


  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
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

  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
United States, Georgia
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 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, 07227
Novartis Investigative Site
Portland, Oregon, United States, 97225
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, West Virginia
Novartis Investigative Site
Charleston, West Virginia, United States, 25304
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, 06490
Novartis Investigative Site
Ankara, Turkey, 06500
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01151410     History of Changes
Other Study ID Numbers: CSPP100A2365E1  2009-017029-20 
Study First Received: June 23, 2010
Results First Received: February 8, 2016
Last Updated: February 8, 2016
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
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 29, 2016