At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
tolvaptandrug
Likely dose
tolvaptan 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 12, 2013·Updated May 16, 2016
In Brief
A Phase 2 clinical trial evaluating tolvaptan for Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). Completed, enrolled 30 participants across 14 sites in 7 countries.
Detailed Summary
This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Denmark, Germany, Hungary, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionJun 2015
TodayJul 2026
First PostedDec 12, 2013
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.6 years ago
Interventions
tolvaptandrug
Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1