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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151410
• Other study ID #: CSPP100A2365E1
• Secondary ID: 2009-017029-20
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2010
• Last updated: February 8, 2016
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesSlovakia: State Institute for Drug ControlTurkey: General Directorate of Pharmaceuticals and PharmacyHungary: National Institute of PharmacyPoland: The Central Register of Clinical TrialsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• 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

Locations

Country	Name	City	State
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Miskolc
Hungary	Novartis Investigative Site	Nyiregyhaza
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Veszprem
Poland	Novartis Investigative Site	Warszawa
Puerto Rico	Novartis Investigative Site	San Juan
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Martin
Slovakia	Novartis Investigative Site	Myjava
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Trnava
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
United States	Novartis Investigative Site	Amarillo	Texas
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Charleston	West Virginia
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Dalton	Georgia
United States	Novartis Investigative Site	Hattiesburg	Mississippi
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Lewiston	Idaho
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Park Ridge	Illinois
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Guatemala,  Hungary,  Poland,  Puerto Rico,  Slovakia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study	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.	Baseline - end of study (Week 52 or Last observation carried forward (LOCF)	No
Secondary	Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study	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.	Baseline - end of study (Week 52 or Last observation carried forward (LOCF)	No
Secondary	Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study	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).	Baseline to end of study (Week 52 or LOCF)	No