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OPC-41061

Phase 2

Chronic Renal Failure | Small molecule | Nephrology |Co-Diagnostics, Inc.|Last Updated: Jan 1, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01895322Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal DialysisPHASE2 COMPLETED 20 — — Jul 1, 2013Aug 1, 2014Jan 1, 20166 Japan
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Study Endpoints
Primary Endpoints
Change in Daily Urine Volume From Baseline
Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.

Change in daily urine volume from baseline during the repeated-administration period (For five days).

Percent Change in Daily Urine Volume From Baseline
100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>

Percent change in daily urine volume from baseline during the repeated-administration period (For five days).

Secondary Endpoints
Change in Body Weight From Baseline
Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
Percent Change in Body Weight
100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OPC-41061EXPERIMENTAL -
Interventions
NameTypeDescription
OPC-41061DRUG -
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Patients diagnosed with chronic renal failure * Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis \[CAPD\]) * Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload \[OR: ...

Countries:Japan
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