A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
NCT ID: NCT03048747
Last Updated: 2020-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
16 participants
INTERVENTIONAL
2017-03-02
2019-03-19
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
TREATMENT
NONE
Study Groups
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Tolvaptan
Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Tolvaptan Oral Tablet
Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Interventions
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Tolvaptan Oral Tablet
Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Eligibility Criteria
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Inclusion Criteria
* Subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination
Exclusion Criteria
* Subjects who are unable to sense thirst or who have difficulty with fluid intake
* Subjects with urinary tract obstruction
* Subjects who have participated in any other clinical trial within 30 days prior to informed consent
* Subjects with serum sodium concentration of \<120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures
20 Years
85 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chubu Region, , Japan
Chugoku Region, , Japan
Kanto Region, , Japan
Kinki Region, , Japan
Kyushu Region, , Japan
Sikoku Region, , Japan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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JapicCTI-173512
Identifier Type: OTHER
Identifier Source: secondary_id
156-14-003
Identifier Type: -
Identifier Source: org_study_id