Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
NCT ID: NCT01447485
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Valsartan 20 mg or 40 mg
Valsartan (VAL489)
Interventions
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Valsartan (VAL489)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
6 Years
14 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Aichi, , Japan
Novartis Investigative Site
Tokyo, , Japan
Countries
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Related Links
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Results for CVAL489K1101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CVAL489K1101
Identifier Type: -
Identifier Source: org_study_id
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