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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

NCT ID: NCT01151410

Last Updated: 2016-03-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Little Rock, Arkansas, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Dalton, Georgia, United States

Site Status

Novartis Investigative Site

Lewiston, Idaho, United States

Site Status

Novartis Investigative Site

Park Ridge, Illinois, United States

Site Status

Novartis Investigative Site

Louisville, Kentucky, United States

Site Status

Novartis Investigative Site

Hattiesburg, Mississippi, United States

Site Status

Novartis Investigative Site

Jackson, Mississippi, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Columbus, Ohio, United States

Site Status

Novartis Investigative Site

Toledo, Ohio, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Amarillo, Texas, United States

Site Status

Novartis Investigative Site

Charleston, West Virginia, United States

Site Status

Novartis Investigative Site

Guatemala City, Departamento de Guatemala, Guatemala

Site Status

Novartis Investigative Site

Nyíregyháza, Hungary, Hungary

Site Status

Novartis Investigative Site

Szeged, Hungary, Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Debrecen, , Hungary

Site Status

Novartis Investigative Site

Miskolc, , Hungary

Site Status

Novartis Investigative Site

Veszprém, , Hungary

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

San Juan, , Puerto Rico

Site Status

Novartis Investigative Site

Bratislava, Slovakia, Slovakia

Site Status

Novartis Investigative Site

Bratislava, Slovakia, Slovakia

Site Status

Novartis Investigative Site

Martin, Slovakia, Slovakia

Site Status

Novartis Investigative Site

Myjava, Slovakia, Slovakia

Site Status

Novartis Investigative Site

Prešov, Slovakia, Slovakia

Site Status

Novartis Investigative Site

Trnava, Slovakia, Slovakia

Site Status

Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

Site Status

Countries

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United States Guatemala Hungary Poland Puerto Rico Slovakia Turkey (Türkiye)

References

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Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

Reference Type DERIVED
PMID: 33089502 (View on PubMed)

Other Identifiers

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2009-017029-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSPP100A2365E1

Identifier Type: -

Identifier Source: org_study_id

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