Expired Study
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Daytona Beach, Florida


Purpose:

This first open-label study in a pediatric population is designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6 - 17 year old children (includes children 6 to less than 18 years of age) with hypertension. The study includes doses (2 mg/kg and 6 mg/kg) that span the dose range researched in adults. The total dose of aliskiren will be calculated based on body weight (maximum 100 kg for inclusion) and will be no greater than 600 mg.


Criteria:

Inclusion Criteria: - Male or female, 6 - 17 years of age (6 to less than 18 years of age at study completion) - Documented history of hypertension - Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization - Able to safely wash out previous antihypertensive therapy for 1 - 2 weeks Exclusion Criteria: - Body weight of < 21 kg (45 lbs.) or > 100 kg (220 lbs.) - Inability to discontinue prior antihypertensive medication as required during the washout period - Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values - Renal artery stenosis - Current diagnosis of heart failure (NYHA Class II-IV) msSBP ≥ 25% above the 95th percentile for age, gender and height at Visit 2 - Second or third degree heart block with or without a pacemaker - Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1 - Evidence of current symptomatic valvular disease Other protocol-defined inclusion/exclusion criteria may apply


Study is Available At:


Original ID:

CSPP100A2256


NCT ID:

NCT00834041


Secondary ID:


Study Acronym:


Brief Title:

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6 - 17 Years of Age


Official Title:

An 8-day Open-label, Multiple-dose, Multi-center Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6 - 17 Years of Age


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

6 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

  • United States: Food and Drug Administration
  • Hungary: National Institute of Pharmacy
  • Brazil: Ministry of Health
  • Belgium: Federal Agency for Medicinal Products and Health Products
  • Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

39


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis
Study Chair
Novartis

Study Dates

Start Date:February 2009
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:June 23, 2010
First Received Date:January 30, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Relationship between change in blood pressure and change in PRA
Time Frame:12 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Relationship between PRA (change from baseline) and age
Time Frame:12 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Relationship between change in PRA and the dose of aliskiren
Time Frame:12 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Dose proportionality on exposure to aliskiren
Time Frame:12 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Effect of age on pharmacokinetics of aliskiren
Time Frame:12 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Evaluate the Safety and tolerability of aliskiren
Time Frame:12 days
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Aliskiren Low Dose
Description:Aliskiren 2 mg/kg body weight
Arm Name:1
Intervention Type:Drug
Name:Aliskiren High Dose
Description:Aliskiren 6 mg/kg body weight
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Aliskiren 6 mg/kg body weight
Study Arm Type:Active Comparator
Arm Name:1
Description:Aliskiren 2 mg/kg body weight

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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