Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447485
• Other study ID #: CVAL489K1101
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Nephrosis
• Nephrotic Syndrome
• Renal Insufficiency, Chronic

Intervention

Drug:
• Valsartan (VAL489)

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Aichi
Japan	Novartis Investigative Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of valsartan in plasma		Up to 24 hours post-dose
Primary	Cmax of valsartan in plasma		Up to 24 hours post-dose
Primary	Tmax of valsartan in plasma		Up to 24 hours post-dose
Primary	T1/2 of valsartan in plasma		Up to 24 hours post-dose
Primary	CL/F of valsartan in plasma		Up to 24 hours post-dose
Secondary	ECG evaluations		24 hours post-dose
Secondary	Standard clinical laboratory evaluations		24 hours post-dose
Secondary	Vital signs		2, 4, and 24 hours post-dose
Secondary	Physical examination		24 hours post-dose
Secondary	Number and severity of adverse events		Up to 24 hours post-dose

External Links

•   Results for CVAL489K1101 can be found on the Novartis Clinical Trial Results Website