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

Otsuka Pharmaceutical Co., Ltd.1 site in 1 country122 target enrollmentAugust 2004

ConditionsHeart Failure, Congestive Edema

DrugsOPC-41061(Tolvaptan)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Heart Failure, Congestive
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Enrollment: 122
Locations: 1
Primary Endpoint: Body Weight
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

January 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, pulmonary congestion, or 3rd sound due to extracellular volume expansion
•Hospitalized patients or patients who can be hospitalized for the study from the commencement of the observation period to the end-of-study examination
•Men and women between the ages of 20 and 80 (non-inclusive) at the time of giving consent
•Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period
•Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration

Exclusion Criteria

•Patients with unstable heart failure (acute heart failure, acute exacerbation of chronic heart failure, etc)
•Patients with an implanted ventricular assist device
•Patients who have undergone or are scheduled to undergo any of the following procedures
•Heart surgery involving thoracotomy within 60 days prior to the screening examination
•Pacemaker implant surgery involving bilateral pacing within 60 days prior to the screening examination
•Angioplasty, electrophysiologic device implantation, ventricular assist device implantation, heart transplant, or other cardiac surgery scheduled within 30 days after the screening examination
•Patients with any of the following diseases, complications, or symptoms
•Suspected hypovolemia
•Onset of acute myocardial infarction within 30 days prior to the screening examination
•Hypertrophic cardiomyopathy (excluding diastolic phase)