| Trial ID: | L0064 |
| Source ID: | NCT02331680
|
| Associated Drug: |
Opc-41061
|
| Title: |
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02331680/results
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: OPC-41061|DRUG: OPC-41061|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change From Baseline in Daily Urine Volume, Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics., Baselineļ¼End of the treatment | Secondary: Change in Total Volume of Fluid Removed by Dialysis Per Week, Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics., Baselineļ¼End of the treatment
|
| Sponsor/Collaborators: |
Sponsor: Otsuka Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
124
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-12
|
| Completion Date: |
2016-05
|
| Results First Posted: |
2019-10-22
|
| Last Update Posted: |
2019-10-22
|
| Locations: |
Kanto, Region, Japan|Kinki, Region, Japan|Kyushu, Region, Japan|Tohoku, Region, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02331680
|
