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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
March 1, 2014
Primary Completion Date
November 1, 2015
Completion Date
November 1, 2015
Last Updated
March 30, 2016
20
ACTUAL participants
Tolvaptan
DRUG
Placebo
DRUG
Lead Sponsor
Mayo Clinic
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