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A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

NCT00234104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2013-12-25

Study results available
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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.

Conditions

  • Heart Failure, Congestive
  • Edema

Interventions

DRUG

OPC-41061(Tolvaptan)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · Division of New Product Evaluation and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00234104 on ClinicalTrials.gov