Trials / Completed
CompletedNCT01895322
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
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 Peritoneal Dialysis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-41061 |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-02-01
- Completion
- 2014-08-01
- First posted
- 2013-07-10
- Last updated
- 2016-01-01
- Results posted
- 2016-01-01
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01895322. Inclusion in this directory is not an endorsement.