Clinical Trials Directory

Trials / Completed

CompletedNCT03342690

Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)

DRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE)

Status
Completed
Phase
Study type
Observational
Enrollment
1,165 (actual)
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
Sex
All
Age
0 Years
Healthy volunteers
Not accepted

Summary

Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

Detailed description

This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.

Conditions

Interventions

TypeNameDescription
DRUGEplerenoneIn adults, usually, administer the initial dose of 25 mg once daily according to the patient's serum potassium level and conditions, increase dosage up to 50 mg once daily after 4 week; patients with moderate renal impairment should start with 25 mg every other day and the maximum dosage should be 25 mg once daily. Also, dose should be reduced or interrupted according to serum potassium level and patient's conditions.

Timeline

Start date
2017-07-05
Primary completion
2020-07-15
Completion
2020-07-15
First posted
2017-11-17
Last updated
2023-07-11
Results posted
2021-06-28

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT03342690. Inclusion in this directory is not an endorsement.