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| Sponsor: | Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00479336 |
Purpose
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite taking conventional diuretics.
| Condition | Intervention | Phase |
|---|---|---|
|
Cirrhosis |
Drug: OPC-41061 7.5mg Drug: OPC-41061 placebo Drug: OPC-41061 15mg Drug: OPC-41601 30mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: OPC-41061 placebo
placebo, 1 tablet a day
|
| Experimental: 2 |
Drug: OPC-41061 7.5mg
7.5mg, 1 tablet a day
|
| Experimental: 3 |
Drug: OPC-41061 15mg
15mg, 1 tablet a day
|
| Experimental: 4 |
Drug: OPC-41601 30mg
30mg, 1 tablet a day
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with ascites despite taking either of the following combinations of loop diuretics and an anti-aldosterone agent (spironolactone) for at least 7 days prior to start of the study drug administration.
Combination 1: Loop diuretics at indicated below in combination with an anti-aldosterone agent at a daily dose of 25 mg or more
Exclusion Criteria:
Contacts and Locations| Japan | |
| Chubu region, Japan | |
| Chugoku region, Japan | |
| Hokkaido region, Japan | |
| Kanto region, Japan | |
| Kinki region, Japan | |
| Kyusyu region, Japan | |
| Tohoku region, Japan | |
| Study Director: | Katsuhisa Saito | Division of New Product Evalution and Development |
More Information
| Responsible Party: | Katsuhisa Saito, OPCJ |
| ClinicalTrials.gov Identifier: | NCT00479336 History of Changes |
| Other Study ID Numbers: | 156-06-005 |
| Study First Received: | May 25, 2007 |
| Last Updated: | July 28, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
OPC-41061 Tolvaptan ascites Cirrhosis |
|
Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Pathologic Processes |