Back to resultsPharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
Primary Purpose
Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Valsartan (VAL489)
Sponsored by
About this trial
This is an interventional basic science trial for Hypertension focused on measuring Hypertension, chronic kidney disease, nephrotic syndrome, pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Exclusion Criteria:
- GFR < 30 mL/min/1.73 m2
- Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
- Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valsartan 20 mg or 40 mg
Arm Description
Outcomes
Primary Outcome Measures
AUC of valsartan in plasma
Cmax of valsartan in plasma
Tmax of valsartan in plasma
T1/2 of valsartan in plasma
CL/F of valsartan in plasma
Secondary Outcome Measures
ECG evaluations
Standard clinical laboratory evaluations
Vital signs
Physical examination
Number and severity of adverse events
Full Information
NCT ID
NCT01447485
First Posted
August 31, 2011
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01447485
Brief Title
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
Official Title
A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
Keywords
Hypertension, chronic kidney disease, nephrotic syndrome, pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsartan 20 mg or 40 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valsartan (VAL489)
Primary Outcome Measure Information:
Title
AUC of valsartan in plasma
Time Frame
Up to 24 hours post-dose
Title
Cmax of valsartan in plasma
Time Frame
Up to 24 hours post-dose
Title
Tmax of valsartan in plasma
Time Frame
Up to 24 hours post-dose
Title
T1/2 of valsartan in plasma
Time Frame
Up to 24 hours post-dose
Title
CL/F of valsartan in plasma
Time Frame
Up to 24 hours post-dose
Secondary Outcome Measure Information:
Title
ECG evaluations
Time Frame
24 hours post-dose
Title
Standard clinical laboratory evaluations
Time Frame
24 hours post-dose
Title
Vital signs
Time Frame
2, 4, and 24 hours post-dose
Title
Physical examination
Time Frame
24 hours post-dose
Title
Number and severity of adverse events
Time Frame
Up to 24 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Exclusion Criteria:
GFR < 30 mL/min/1.73 m2
Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aichi
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6883
Description
Results for CVAL489K1101 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
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