CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
OPC-41061(Tolvaptan)drug
Likely dose
OPC-41061 (Tolvaptan) dose to be determined (dose-response study)AI-extracted
Key inclusion· 5
  • ✓CHF with clinical signs of extracellular volume expansion (edema, jugular venous distention, hepatomegaly, pulmonary congestion, or 3rd heart sound)
  • ✓Hospitalized or able to be hospitalized for the duration of the study
  • ✓Age 20–80 years (non-inclusive)
  • ✓On furosemide ≥40 mg/day orally with stable dosing for ≥3 days before screening
Key exclusion· 15
  • ✕Unstable heart failure (acute HF, acute exacerbation of chronic HF)
  • ✕Implanted ventricular assist device
  • ✕Recent major cardiac surgery (thoracotomy within 60 days) or pacemaker implant (bilateral pacing within 60 days)
  • ✕Planned cardiac interventions within 30 days of screening (angioplasty, device implant, heart transplant, or cardiac surgery)

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

Search/NCT00234104
NCT00234104Phase 2Completed
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Dose Response of OPC-41061 in Congestive Heart Failure Patients With Extracellular Volume Expansion

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 6, 2005·Updated Dec 25, 2013

In Brief

A Phase 2 clinical trial evaluating OPC-41061(Tolvaptan) for Heart Failure, Congestive and Edema. Completed, enrolled 122 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive, Edema
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartAug 1, 2004
Primary CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.7 years ago

Interventions

OPC-41061(Tolvaptan)drug