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

NCT00462670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2014-02-04

Study results available
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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

Interventions

DRUG

OPC-41061(Tolvaptan)

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

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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Japan

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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 NCT00462670 on ClinicalTrials.gov