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| Sponsor: | Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00234104 |
Purpose
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 |
|---|---|---|
|
Heart Failure, Congestive Edema |
Drug: OPC-41061(Tolvaptan) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| 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
Contacts and Locations
More Information
| Responsible Party: | Katsuhisa Saito, OPCJ |
| ClinicalTrials.gov Identifier: | NCT00234104 History of Changes |
| Other Study ID Numbers: | 156-03-001, JapicCTI-050038 |
| Study First Received: | October 4, 2005 |
| Last Updated: | April 23, 2008 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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OPC-41061 Tolvaptan Heart Failure Edema Extracellular volume expansion |
|
Edema Heart Failure Signs and Symptoms Heart Diseases Cardiovascular Diseases |