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Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447485
First Posted: October 6, 2011
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: None (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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • AUC of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ]
  • Cmax of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ]
  • Tmax of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ]
  • T1/2 of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ]
  • CL/F of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01447485     History of Changes
Other Study ID Numbers: CVAL489K1101
First Submitted: August 31, 2011
First Posted: October 6, 2011
Last Update Posted: May 8, 2012
Last Verified: May 2012

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

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