Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) - an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg
Sponsor study identifier
interventional
52
1 country
6
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
February 2009
Actual (reported)To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 15, 2007
Actual (reported)October 16, 2007
Actual (reported)February 2009
Actual (reported)February 2009
Actual (reported)January 30, 2014
Actual (reported)Body Weight
The change of body weight from baseline at final observation
Baseline, Day 14 or at the time of final drug administration
15-30mg/day,daily for 14days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chubu Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyuush, Japan
Shikoku Region, Japan
Katsuhisa Saito
Division of New Product Evaluation and Development
52 participants (actual enrollment reported by the registry).
First Submitted
October 15, 2007
First Posted
October 16, 2007
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2009
Actual (reported)Study Completion
February 2009
Actual (reported)Last Updated
January 30, 2014
Results First Posted
January 30, 2014
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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