Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

  Show 85 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: 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
Cardiovascular Diseases
Vascular Diseases
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014