A Double-Blind, Placebo-Controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure) - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00462670

Purpose

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.

Condition	Intervention	Phase
Edema, Cardiac	Drug: OPC-41061(Tolvaptan)	Phase III

MedlinePlus related topics: Edema Heart Failure

Drug Information available for: Tolvaptan Argipressin Vasopressins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Body weight (amount of change) [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Body weight (rate of change) [ Time Frame: each day ] [ Designated as safety issue: Yes ]
Lower limb edema, pulmonary congestion, other edema, jugular venous distention, hepatomegaly, pulmonary rales, third heart sound, cardiothoracic ratio [ Time Frame: each day ] [ Designated as safety issue: Yes ]
Echocardiography [Transmitral flow (TMF) E-wave /A-wave velocity ratio, TMF E-wave deceleration time, pulmonary venous flow (PVF) S-wave velocity and D-wave deceleration time, and difference between PVF A-wave duration and TMF A-wave duration (TPA-TMA)] [ Time Frame: last day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	April 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 0mg	Drug: OPC-41061(Tolvaptan) 0, 15mg of OPC-41061 per day for 7days p.o. administration
2: Experimental 15mg OPC-41061	Drug: OPC-41061(Tolvaptan) 0, 15mg of OPC-41061 per day for 7days p.o. administration

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)
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.
Male or female subjects age 20 or older and younger than 85 (at time of informed consent)
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)
Subjects capable of giving informed consent to participate in the study of their own free will

Exclusion Criteria:

Subjects with acute heart failure
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 a definite 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 such as mozavaptan hydrochloride or benazepril hydrochloride.
Subjects who are obese [body mass index (BMI, body weight (kg)/height (m)2 exceeding 35]
Patients with supine systolic blood pressure exceeding 90 mmHg
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
Patients 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462670

Locations

Japan

Hokkaido region, Japan

Tohoku region, Japan

Kanto region, Japan

Chubu region, Japan

Kyushu region, Japan

Chugoku region, Japan

Shikoku region, Japan

Kinki region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

Division of New Product Evaluation and Development

More Information

Responsible Party:	OPCJ ( Katsuhisa Saito )
Study ID Numbers:	156-06-002
Study First Received:	April 17, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00462670
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

Cardiac edema
OPC-41061
Vasopressin antagonist

Study placed in the following topic categories:

Arginine Vasopressin
Signs and Symptoms
Heart Failure
Heart Diseases

Edema, Cardiac
Vasopressins
Edema

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009