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NCT Number: NCT01447485

Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Nephrotic Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valsartan (VAL489)

Drug

Primary outcomes

  1. AUC of valsartan in plasma

    Time frame: Up to 24 hours post-dose

  2. Cmax of valsartan in plasma

    Time frame: Up to 24 hours post-dose

  3. Tmax of valsartan in plasma

    Time frame: Up to 24 hours post-dose

  4. T1/2 of valsartan in plasma

    Time frame: Up to 24 hours post-dose

  5. CL/F of valsartan in plasma

    Time frame: Up to 24 hours post-dose

Secondary outcomes

  1. ECG evaluations

    Time frame: 24 hours post-dose

  2. Standard clinical laboratory evaluations

    Time frame: 24 hours post-dose

  3. Vital signs

    Time frame: 2, 4, and 24 hours post-dose

  4. Physical examination

    Time frame: 24 hours post-dose

  5. Number and severity of adverse events

    Time frame: Up to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2011
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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