NCT01439009

Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients

A Multi-center,_double-blind,_pararel-group Comparison Trial to Investigate the Effect of Short-term Administration of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients (Phase_4 Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Tolvaptan	Once-daily oral administration of one tolvaptan 15 mg tablet in the morning
DRUG	Placebo of tolvaptan	Once-daily oral administration of one placebo tablet in the morning

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-09-22
• Last updated: 2019-10-22
• Results posted: 2019-10-22

Locations

8 sites across 1 country: Japan