| Trial ID: | L0069 |
| Source ID: | NCT01876381
|
| Associated Drug: |
Opc-41061
|
| Title: |
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01876381/results
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: OPC-41061
|
| Outcome Measures: |
Primary: Change From Baseline in Daily Urine Volume, The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation \[SD\], minimum, median, maximum \[same for following parameters\])., Baseline and Day 14 (Intermittent Administration Period) | Secondary: Change From Baseline in Total Fluid Removal Per Week by Dialysis, The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics., Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)
|
| Sponsor/Collaborators: |
Sponsor: Otsuka Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
26
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2014-02
|
| Results First Posted: |
2018-08-24
|
| Last Update Posted: |
2018-08-24
|
| Locations: |
Chube Region, Japan|Kanto Region, Japan|Kinki Region, Japan|Kyushu Region, Japan|Tohoku Region, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01876381
|
