A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

NCT ID: NCT00462670

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-10-31

Brief Summary

To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.

Conditions

Edema, Cardiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

0mg

Group Type: PLACEBO_COMPARATOR

OPC-41061(Tolvaptan)

Intervention Type: DRUG

0, 15mg of OPC-41061 per day for 7days p.o. administration

2

15mg OPC-41061

Group Type: EXPERIMENTAL

OPC-41061(Tolvaptan)

Intervention Type: DRUG

0, 15mg of OPC-41061 per day for 7days p.o. administration

Interventions

OPC-41061(Tolvaptan)

0, 15mg of OPC-41061 per day for 7days p.o. administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects receiving one of the following diuretic treatments (including subjects scheduled to start treatment during the run-in observation period, 1)A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide, 2)Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses), 3)Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)

2. CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion Patients with pulmonary congestion can be enrolled if pulmonary congestion is confirmed on chest x-ray taken within 14 days prior to the screening examination.

3. Male or female subjects age 20 or older and younger than 85 (at time of informed consent)

4. Subjects who are able to stay at the study site from the day before the start of the run-in observation period until completion of postdosing examination 2 (7 to 10 days after final study drug administration)

5. Subjects capable of giving informed consent to participate in the study of their own free will

Exclusion Criteria

1. Subjects with acute heart failure

2. Subjects with an assisted circulation device

3. 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

4. Subjects who develop acute myocardial infarction within 30 days prior to the screening examination

5. Subjects with a definite diagnosis of active myocarditis or amyloid cardiomyopathy

6. 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

7. 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 such as mozavaptan hydrochloride or benazepril hydrochloride.

8. Subjects who are obese [body mass index (BMI, body weight (kg)/height (m)2 exceeding 35]

9. Patients with supine systolic blood pressure exceeding 90 mmHg

10. Subjects with any of following abnormal laboratory values: (1)Total bilirubin exceeding 3.0 mg/dL, (2)serum creatinine exceeding 3.0 mg/dL, (3)serum sodium exceeding 147 mEq/L, (4)serum potassium exceeding 5.5 mEq/L

11. Patients who are unable to take oral medication

12. Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant

13. Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination

14. Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061

15. Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katsuhisa Saito

Role: STUDY_DIRECTOR

Division of New Product Evaluation and Development

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

156-06-002

Identifier Type: -

Identifier Source: org_study_id