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

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Enalapril (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300

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).

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

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

Primary outcome: 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.

Secondary outcome:

Mean sitting systolic blood pressure reduction of long-term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old

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

Mean sitting diastolic blood pressure reduction of long-term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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

Novartis Pharmaceuticals, Phone: 862-778-8300

Novartis Investigative Site, Edegem 2650, Belgium; Not yet recruiting

Novartis Investigative Site, Gent 9000, Belgium; Not yet recruiting

Novartis Investigative Site, Jette 1090, Belgium; Recruiting

Novartis Investigative Site, Laeken 1020, Belgium; Not yet recruiting

Novartis Investigative Site, Leuven 3000, Belgium; Recruiting

Novartis Investigative Site, Dortmund 44137, Germany; Not yet recruiting

Novartis Investigative Site, Erlangen 91054, Germany; Not yet recruiting

Novartis Investigative Site, Göttingen D-37075, Germany; Not yet recruiting

Novartis Investigative Site, Göttingen 37073, Germany; Not yet recruiting

Novartis Investigative Site, Hamburg 20246, Germany; Completed

Novartis Investigative Site, Heidelberg 69120, Germany; Not yet recruiting

Novartis Investigative Site, Marburg 35039, Germany; Recruiting

Novartis Investigative Site, Muenchen 81377, Germany; Withdrawn

Novartis Investigative Site, Budapest 1094, Hungary; Withdrawn

Novartis Investigative Site, Budapest 1131, Hungary; Recruiting

Novartis Investigative Site, Budapest 1083, Hungary; Recruiting

Novartis Investigative Site, Debrecen 4032, Hungary; Recruiting

Novartis Investigative Site, Miskolc 3526, Hungary; Recruiting

Novartis Investigative Site, Nyiregyhaza 4400, Hungary; Recruiting

Novartis Investigative Site, Szeged 6725, Hungary; Recruiting

Novartis Investigative Site, Veszprem H-8200, Hungary; Recruiting

Novartis Investigative Site, Gdansk 80-952, Poland; Withdrawn

Novartis Investigative Site, Krakow 30-663, Poland; Withdrawn

Novartis Investigative Site, Poznan 60-572, Poland; Withdrawn

Novartis Investigative Site, Warszawa 04-154, Poland; Recruiting

Novartis Investigative Site, Warszawa 04-730, Poland; Withdrawn

Novartis Investigative Site, San Juan 00907, Puerto Rico; Recruiting

Novartis Investigative Site, Bratislava 84103, Slovakia; Recruiting

Novartis Investigative Site, Bratislava 85107, Slovakia; Recruiting

Novartis Investigative Site, Martin 03601, Slovakia; Recruiting

Novartis Investigative Site, Myjava 90701, Slovakia; Recruiting

Novartis Investigative Site, Presov 08001, Slovakia; Not yet recruiting

Novartis Investigative Site, Trnava 91701, Slovakia; Recruiting

Novartis Investigative Site, Trnava 91701, Slovakia; Not yet recruiting

Novartis Investigative Site, Ankara 06500, Turkey; Not yet recruiting

Novartis Investigative Site, Ankara 06100, Turkey; Not yet recruiting

Novartis Investigative Site, Ankara 06490, Turkey; Not yet recruiting

Novartis Investigative Site, Izmir 35340, Turkey; Not yet recruiting

Novartis Investigative Site, Birmingham, Alabama 35294-0006, United States; Recruiting

Novartis Investigative Site, Little Rock, Arkansas 72202, United States; Recruiting

Novartis Investigative Site, Anaheim, California 92805, United States; Not yet recruiting

Novartis Investigative Site, Los Angeles, California 90048, United States; Recruiting

Novartis Investigative Site, San Diego, California 92123, United States; Recruiting

Novartis Investigative Site, Hartford, Connecticut 06106, United States; Withdrawn

Novartis Investigative Site, Miami, Florida 33125, United States; Withdrawn

Novartis Investigative Site, Miami, Florida 33155, United States; Withdrawn

Novartis Investigative Site, Miami, Florida 33136, United States; Not yet recruiting

Novartis Investigative Site, Pensacola, Florida 32504, United States; Not yet recruiting

Novartis Investigative Site, Atlanta, Georgia 30322, United States; Not yet recruiting

Novartis Investigative Site, Augusta, Georgia 30909, United States; Withdrawn

Novartis Investigative Site, Dalton, Georgia 30721, United States; Recruiting

Novartis Investigative Site, Honolulu, Hawaii 96813, United States; Recruiting

Novartis Investigative Site, Lewiston, Idaho 83501, United States; Completed

Novartis Investigative Site, Park Ridge, Illinois 60068, United States; Recruiting

Novartis Investigative Site, Louisville, Kentucky 40202, United States; Recruiting

Novartis Investigative Site, Boston, Massachusetts 02115, United States; Recruiting

Novartis Investigative Site, Hattiesburg, Mississippi 39401, United States; Recruiting

Novartis Investigative Site, Jackson, Mississippi 39209, United States; Recruiting

Novartis Investigative Site, Jackson, Mississippi 39216-9941, United States; Withdrawn

Novartis Investigative Site, Omaha, Nebraska 68198-3020, United States; Withdrawn

Novartis Investigative Site, Hackensack, New Jersey 07601, United States; Not yet recruiting

Novartis Investigative Site, New Hyde Park, New York 11040, United States; Withdrawn

Novartis Investigative Site, New York, New York 10016, United States; Not yet recruiting

Novartis Investigative Site, Cincinnati, Ohio 45229-3039, United States; Terminated

Novartis Investigative Site, Cleveland, Ohio 44106, United States; Not yet recruiting

Novartis Investigative Site, Columbus, Ohio 43205, United States; Completed

Novartis Investigative Site, Toledo, Ohio 43606, United States; Recruiting

Novartis Investigative Site, Portland, Oregon 97225, United States; Recruiting

Novartis Investigative Site, Portland, Oregon 07227, United States; Completed

Novartis Investigative Site, Charleston, South Carolina 29425, United States; Recruiting

Novartis Investigative Site, Memphis, Tennessee 38103, United States; Withdrawn

Novartis Investigative Site, Dallas, Texas 75235, United States; Withdrawn

Novartis Investigative Site, Houston, Texas 77030, United States; Withdrawn

Novartis Investigative Site, Houston, Texas 77021, United States; Not yet recruiting

Novartis Investigative Site, San Antonio, Texas 78229-4801, United States; Withdrawn

Novartis Investigative Site, Charlottesville, Virginia 22908, United States; Not yet recruiting

Novartis Investigative Site, Norfolk, Virginia 23507, United States; Recruiting

Novartis Investigative Site, Seattle, Washington 98105, United States; Recruiting

Novartis Investigative Site, Charleston, West Virginia 25304, United States; Recruiting

Novartis Investigative Site, Milwaukee, Wisconsin 53226, United States; Withdrawn

Starting date: August 2010
Last updated: January 2, 2013