Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients.

Phase 1

• Conditions: Hypertension, Chronic Kidney Disease, Nephrotic Syndrome; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-004445-10-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-07
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•apanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome

Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified