Trials / Completed
CompletedNCT01114828
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
A Multi-center, Double-blind, Parallel-arm Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-41061 | Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days |
| DRUG | OPC-41061 | Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2011-10-01
- Completion
- 2011-12-01
- First posted
- 2010-05-03
- Last updated
- 2014-03-04
- Results posted
- 2014-01-31
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01114828. Inclusion in this directory is not an endorsement.