Trials Sponsors Conditions Drugs Pricing

Conditions

Edema, Cardiac

Keywords

Cardiac edemaOPC-41061Vasopressin antagonist

Outcome Measures

Primary Outcomes (1)

Body Weight (Amount of Change)
Change in body weight from baseline at the time of final trial drug administration
baseline, Day 7 or at the time of final trial drug administration

Secondary Outcomes (1)

Body Weight (Percent Change)
baseline, Day 7 or at the time of final trial drug administration

Study Arms (2)

1

PLACEBO COMPARATOR

0mg

Drug: OPC-41061(Tolvaptan)

2

EXPERIMENTAL

15mg OPC-41061

Drug: OPC-41061(Tolvaptan)

Interventions

OPC-41061(Tolvaptan)Drug

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

Eligibility Criteria

Age20 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (8)

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kanto Region, Japan

Kinki Region, Japan

Kyushu Region, Japan

Shikoku Region, Japan

Tohoku Region, Japan

MeSH Terms

Conditions

Edema, Cardiac

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesEdemaSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd.

Study Officials

Katsuhisa Saito
Division of New Product Evaluation and Development
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

110 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 19, 2007

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations