Viewing Study NCT02096965



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Last Modification Date: 2024-10-26 @ 11:21 AM
Study NCT ID: NCT02096965
Status: COMPLETED
Last Update Posted: 2016-03-30
First Post: 2014-03-24

Brief Title: Use of Tolvaptan to Reduce Urinary Supersaturation a Pilot Proof of Principle Study
Sponsor: Mayo Clinic
Organization: Mayo Clinic

Study Overview

Official Title: Use of Tolvaptan to Reduce Urinary Supersaturation a Pilot Proof of Principle Study
Status: COMPLETED
Status Verified Date: 2016-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this study the investigators propose to use a daily dose of 45 mg 30 mg at 8 AM and 15 mg at 4 PM This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function see below The twice-daily 8 AM and 4 PM regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night To this end a higher dose is used in the morning with a lower dose in the afternoon
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None