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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00234104 |
This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.
Condition | Intervention | Phase |
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Heart Failure, Congestive Edema |
Drug: OPC-41061(Tolvaptan) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Dose Response of OPC-41061 in Congestive Heart Failure Patients With Extracellular Volume Expansion |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who have undergone or are scheduled to undergo any of the following procedures
Patients with any of the following diseases, complications, or symptoms
Patients with a history of the following conditions
Responsible Party: | OPCJ ( Katsuhisa Saito ) |
Study ID Numbers: | 156-03-001, JapicCTI-050038 |
Study First Received: | October 4, 2005 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00234104 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
OPC-41061 Tolvaptan Heart Failure Edema Extracellular volume expansion |
Signs and Symptoms Heart Failure Heart Diseases Edema, Cardiac Edema |
Cardiovascular Diseases |