Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01447485
First received: August 31, 2011
Last updated: May 6, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Chronic Kidney Disease
Nephrotic Syndrome
Drug: Valsartan (VAL489)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • AUC of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Cmax of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Tmax of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • T1/2 of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • CL/F of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ECG evaluations [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: Yes ]
  • Standard clinical laboratory evaluations [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 2, 4, and 24 hours post-dose ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: Yes ]
  • Number and severity of adverse events [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan 20 mg or 40 mg Drug: Valsartan (VAL489)

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447485

Locations
Japan
Novartis Investigative Site
Aichi, Japan
Novartis Investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01447485     History of Changes
Other Study ID Numbers: CVAL489K1101
Study First Received: August 31, 2011
Last Updated: May 6, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Hypertension, chronic kidney disease
nephrotic syndrome
pharmacokinetics

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Nephrotic Syndrome
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Nephrosis
Renal Insufficiency
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014