Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hypertension
Started Aug 2011
Shorter than P25 for phase_1 hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedDecember 21, 2020
May 1, 2012
2 months
August 31, 2011
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
AUC of valsartan in plasma
Up to 24 hours post-dose
Cmax of valsartan in plasma
Up to 24 hours post-dose
Tmax of valsartan in plasma
Up to 24 hours post-dose
T1/2 of valsartan in plasma
Up to 24 hours post-dose
CL/F of valsartan in plasma
Up to 24 hours post-dose
Secondary Outcomes (5)
ECG evaluations
24 hours post-dose
Standard clinical laboratory evaluations
24 hours post-dose
Vital signs
2, 4, and 24 hours post-dose
Physical examination
24 hours post-dose
Number and severity of adverse events
Up to 24 hours post-dose
Study Arms (1)
Valsartan 20 mg or 40 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novartis Investigative Site
Aichi, Japan
Novartis Investigative Site
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2011
First Posted
October 6, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 21, 2020
Record last verified: 2012-05