MedTrace Logo

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

NCT01439009 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-22

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Japan

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01439009 on ClinicalTrials.gov