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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00479336 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Dose-Defining Study of OPC-41061 in Treatment of Hepatic Edema |
Estimated Enrollment: | 100 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: OPC-41061 placebo
placebo, 1 tablet a day
|
2: Experimental |
Drug: OPC-41061 7.5mg
7.5mg, 1 tablet a day
|
3: Experimental |
Drug: OPC-41061 15mg
15mg, 1 tablet a day
|
4: Experimental |
Drug: OPC-41601 30mg
30mg, 1 tablet a day
|
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:
Japan | |
Tohoku region, Japan | |
Kanto region, Japan | |
Chubu region, Japan | |
Hokkaido region, Japan | |
Kyusyu region, Japan | |
Kinki region, Japan | |
Chugoku region, Japan |
Study Director: | Katsuhisa Saito | Division of New Product Evalution and Development |
Responsible Party: | OPCJ ( Katsuhisa Saito ) |
Study ID Numbers: | 156-06-005 |
Study First Received: | May 25, 2007 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00479336 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
OPC-41061 Tolvaptan ascites Cirrhosis |
Liver Diseases Digestive System Diseases Fibrosis |
Ascites Edema Liver Cirrhosis |
Liver Diseases Pathologic Processes Digestive System Diseases Fibrosis Liver Cirrhosis |