A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00525265 |
Recruitment Status :
Completed
First Posted : September 5, 2007
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiac Edema | Drug: OPC-41061(Tolvaptan) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure) |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
OPC-41061
|
Drug: OPC-41061(Tolvaptan)
Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days. |
Placebo Comparator: 2
placebo
|
Drug: Placebo
Subjects will be orally administered placebo once daily after breakfast for seven days. |
- Body Weight [ Time Frame: Baseline, at the time of final trial drug administration ]The body weight change from baseline at the time of final trial drug administration

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
- Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
- CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- Male or female subjects between the age of 20 and 85, inclusive.
- Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination 2.
- Subjects capable of giving informed consent to participate in the study of their own free will.
Exclusion Criteria:
- Subjects with heart failure with markedly fluctuating symptoms.
- Subjects with an assisted circulation device.
- Subjects with any of the following complications or symptoms:(1)Suspected decrease in circulatory blood flow,(2)Hypertrophic cardiomyopathy (other than dilated phase),(3)Cardiac valve disease with significant heart valve stenosis,(4)Hepatic coma.
- Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
- Subjects with well-defined diagnosis of active myocarditis or amyloid cardiomyopathy.
- Subjects with any of the following complications or symptoms:(1)Diabetes mellitus with poorly controlled blood glucose,(2)Anuria,(3)Urination impaired due to urinary tract stricture,urinary calculus,tumor in urinary tract,or other cause.
- Subjects with a history of any of the following diseases:(1)Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in patients without an implanted defibrillator,(2)Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction),(3)Hypersensitivity or idiosyncratic reaction to benzazepine derivatives.
- Subjects who are morbidly obese (body mass index exceeding 35).
- Subjects with systolic blood pressure in the decubitus position below 90 mmHg.
- Subjects with any of the following abnormal laboratory values:(1)Total bilirubin > 3.0 mg/dL,(2) serum creatinine > 3.0 mg/dL,(3)serum sodium > 147 mEq/L,(4)serum potassium > 5.5 mEq/L.
- Subjects who are unable to take oral medication.
- Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
- Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination.
- Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061.
- Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525265
Japan | |
Kanto region, Japan | |
Kyushu region, Japan |
Study Director: | Katsuhisa Saito | Division of New Product Evaluation and Development |
Responsible Party: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00525265 |
Other Study ID Numbers: |
156-06-004 |
First Posted: | September 5, 2007 Key Record Dates |
Results First Posted: | December 25, 2013 |
Last Update Posted: | December 25, 2013 |
Last Verified: | November 2013 |
Vasopressin antagonist Cardiac Edema Diuretics |
Heart Failure Edema, Cardiac Edema Heart Diseases Cardiovascular Diseases |
Tolvaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |