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

NCT01151410 | Completed Phase 3 Results

• 2 other identifiers: CSPP100A2365E12009-017029-20
• Study Type: interventional
• Target: 208
• Locations: 7 countries
• Sites: 36

Brief 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).

Conditions

Hypertension

Keywords

Pediatric hypertension; primary hypertension; secondary; hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study

  Baseline - end of study (Week 52 or Last observation carried forward (LOCF)

• Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study

  Baseline to end of study (Week 52 or LOCF)

Study Arms (2)

Aliskiren

EXPERIMENTAL

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

Enalapril

ACTIVE COMPARATOR

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

Interventions

Aliskiren 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

Aliskiren

Enalapril 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

Enalapril

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (36)

Novartis Investigative Site

Birmingham, Alabama, 35294-0006, United States

Location

Novartis Investigative Site

Little Rock, Arkansas, 72202, United States

Location

Novartis Investigative Site

Los Angeles, California, 90048, United States

Location

Novartis Investigative Site

Dalton, Georgia, 30721, United States

Location

Novartis Investigative Site

Lewiston, Idaho, 83501, United States

Location

Novartis Investigative Site

Park Ridge, Illinois, 60068, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40202, United States

Location

Novartis Investigative Site

Hattiesburg, Mississippi, 39401, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39209, United States

Location

Novartis Investigative Site

New York, New York, 10016, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43205, United States

Location

Novartis Investigative Site

Toledo, Ohio, 43606, United States

Location

Novartis Investigative Site

Portland, Oregon, 07227, United States

Location

Novartis Investigative Site

Portland, Oregon, 97225, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29425, United States

Location

Novartis Investigative Site

Amarillo, Texas, 79106, United States

Location

Novartis Investigative Site

Charleston, West Virginia, 25304, United States

Location

Novartis Investigative Site

Guatemala City, Departamento de Guatemala, 01010, Guatemala

Location

Novartis Investigative Site

Nyíregyháza, Hungary, 4400, Hungary

Location

Novartis Investigative Site

Szeged, Hungary, 6725, Hungary

Location

Novartis Investigative Site

Budapest, 1083, Hungary

Location

Novartis Investigative Site

Budapest, 1131, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Miskolc, 3529, Hungary

Location

Novartis Investigative Site

Veszprém, H-8200, Hungary

Location

Novartis Investigative Site

Warsaw, 04-154, Poland

Location

Novartis Investigative Site

San Juan, 00907, Puerto Rico

Location

Novartis Investigative Site

Bratislava, Slovakia, 84103, Slovakia

Location

Novartis Investigative Site

Bratislava, Slovakia, 85107, Slovakia

Location

Novartis Investigative Site

Martin, Slovakia, 03601, Slovakia

Location

Novartis Investigative Site

Myjava, Slovakia, 90701, Slovakia

Location

Novartis Investigative Site

Prešov, Slovakia, 08001, Slovakia

Location

Novartis Investigative Site

Trnava, Slovakia, 91701, Slovakia

Location

Novartis Investigative Site

Ankara, Turkey, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey, 06490, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey, 06500, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33089502 DERIVED

MeSH Terms

Conditions

Hypertension; Essential Hypertension; Neoplasm Metastasis

Interventions

aliskiren; Enalapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 -778 -8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 28, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-01

Locations

GU (1); US (17); PR (1); HU (7); SL (6); PL (1); TU (3)