NCT00234104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
8 years until next milestone

Results Posted

Study results publicly available

December 25, 2013

Completed
Last Updated

December 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.4 years

First QC Date

October 4, 2005

Results QC Date

November 1, 2013

Last Update Submit

November 6, 2013

Conditions

Heart Failure, CongestiveEdema

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

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.
+81-3-6361-7314

Study Officials

  • Katsuhisa Saito

    Division of New Product Evaluation and Development

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

December 25, 2013

Results First Posted

December 25, 2013

Record last verified: 2013-11

Locations

JP(1)