At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 20 enrolled

Drug / intervention

OPC-41061(Tolvaptan) +1 moredrug

Likely dose

OPC-41061(Tolvaptan) 7.5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00525265

NCT00525265Phase 3Completed

Compare CT.gov

A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Sep 5, 2007·Updated Dec 25, 2013

In Brief

A Phase 3 clinical trial evaluating OPC-41061(Tolvaptan) and Placebo for Cardiac Edema. Completed, enrolled 20 participants across 2 sites.

Detailed Summary

To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCardiac Edema

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2007

First PostedSep 2007

Primary CompletionJan 2009

TodayJul 2026

First PostedSep 5, 2007

Enrollment StartSep 1, 2007

Primary CompletionJan 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 18.8 years ago

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.