CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
FK949Edrug
Likely dose
Not stated in 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.

Search/NCT01737268
NCT01737268Phase 3Completed
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Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-

Astellas Pharma Inc·interventional·Posted Nov 29, 2012·Updated Nov 19, 2024

In Brief

A Phase 3 clinical trial evaluating FK949E for Bipolar Disorder and Elderly. Completed, enrolled 20 participants across 32 sites.

Detailed Summary

FK949E was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Elderly
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2012
Enrollment StartOct 29, 2012
Primary CompletionJun 29, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.6 years ago

Interventions

FK949Edrug

Oral tablet