Status:
COMPLETED
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Chronic Kidney Disease
Eligibility:
All Genders
6-14 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01447485
Start Date
August 1 2011
End Date
October 1 2011
Last Update
December 21 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Aichi, Japan
2
Novartis Investigative Site
Tokyo, Japan