Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiac Edema

Keywords

Vasopressin antagonistCardiac EdemaDiuretics

Outcome Measures

Primary Outcomes (1)

Body Weight
The body weight change from baseline at the time of final trial drug administration
Baseline, at the time of final trial drug administration

Study Arms (2)

1

EXPERIMENTAL

OPC-41061

Drug: OPC-41061(Tolvaptan)

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

OPC-41061(Tolvaptan)Drug

Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.

PlaceboDrug

Subjects will be orally administered placebo once daily after breakfast for seven days.

Eligibility Criteria

Age20 Years - 85 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (2)

Kanto Region, Japan

Kyushu 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

20 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

September 3, 2007

First Posted

September 5, 2007

Study Start

September 2007

Date type not reported

This date has not been verified as actual or estimated.

A Clinical Pharmacological 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)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

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)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

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