NCT00234104

CompletedPhase 2

A Dose-finding Study of OPC-41061 in Treatment of Cardiac Ed...

Otsuka Pharmaceutical Co., Ltd.Source

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

156-03-001

Secondary identifiers

JapicCTI-050038

Study Type

interventional

Actual enrollment (reported)

122

Locations

1 country

Sites

1

Timeline

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2006

Actual (reported)

Study Completion

January 2006

Actual (reported)

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 Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 122 participants
Study completion date: January 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 4, 2005
Actual (reported)
First Posted
October 6, 2005
Actual (reported)
Primary Completion
January 2006
Actual (reported)
Study Completion
January 2006
Actual (reported)
Results Posted
December 25, 2013
Actual (reported)

Last Updated: December 25, 2013
Status Verified: November 2013
Results QC Date: November 6, 2013
Last Update Submitted: November 6, 2013

Conditions

Heart Failure, Congestive Edema

Keywords

OPC-41061TolvaptanHeart FailureEdemaExtracellular volume expansion

Outcome Measures

Primary Outcomes (1)

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

Interventions

OPC-41061(Tolvaptan)Drug

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

MeSH Terms

Conditions

Heart FailureEdema

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns 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

122 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

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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

You may not qualify if:

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)
Definitively diagnosed active myocarditis or amyloid cardiomyopathy
Valvular heart disease with significant stenosis
Untreated thyroid disease
Progressive neurological disease (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc) or severe episodic neurological disease (epilepsy, Guillain-Barre syndrome, etc)
Diabetes with poor glycemic control
+17 more criteria

Contact the study team to confirm eligibility.

Primary Completion

January 2006

Actual (reported)

Study Completion

January 2006

Actual (reported)

Last Updated

December 25, 2013

Results First Posted

December 25, 2013

Record last verified: 2013-11

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00234104
Data provider: ClinicalTrials.gov
Source updated: 2013-12-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:44 UTC

Locations

JP(1)

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)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

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