Trials / Completed
CompletedNCT02331680
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-41061 | |
| DRUG | OPC-41061 | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2015-01-06
- Last updated
- 2019-10-22
- Results posted
- 2019-10-22
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02331680. Inclusion in this directory is not an endorsement.