Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study
NCT ID: NCT02096965
Last Updated: 2016-03-30
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
20 participants
INTERVENTIONAL
2014-03-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Tolvaptan first, then Placebo
Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period)
Tolvaptan
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
Placebo
Patients will receive daily dose at 8 AM and at 4 PM.
Placebo first, then Tolvaptan
Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period)
Tolvaptan
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
Placebo
Patients will receive daily dose at 8 AM and at 4 PM.
Interventions
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Tolvaptan
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
Placebo
Patients will receive daily dose at 8 AM and at 4 PM.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good renal function
Exclusion Criteria
* History of hypotension or orthostatic dizziness.
* Clinical history of congestive heart failure.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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John Lieske
Principal Investigator
Principal Investigators
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John Lieske, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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11-001780
Identifier Type: -
Identifier Source: org_study_id
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