| Trial ID: | L0065 |
| Source ID: | NCT01895322
|
| Associated Drug: |
Opc-41061
|
| Title: |
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01895322/results
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: OPC-41061
|
| Outcome Measures: |
Primary: Change in Daily Urine Volume From Baseline, Change in daily urine volume from baseline during the repeated-administration period (For five days)., Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.|Percent Change in Daily Urine Volume From Baseline, Percent change in daily urine volume from baseline during the repeated-administration period (For five days)., 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> | Secondary: Change in Body Weight From Baseline, Change in body weight from baseline during the repeated-administration period(For five days)., Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period|Percent Change in Body Weight, Percent change in body weight from baseline during the repeated-administration period(For five days)., 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
|
| Sponsor/Collaborators: |
Sponsor: Otsuka Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-07
|
| Completion Date: |
2014-08
|
| Results First Posted: |
2016-01-01
|
| Last Update Posted: |
2016-01-01
|
| Locations: |
Chubu Region, Japan|Hokkaido Region, Japan|Kanto Region, Japan|Kyushu Region, Japan|Shikoku Region, Japan|Tohoku Region, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01895322
|
