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

NCT03342690 | Completed Results

• 1 other identifier: A6141122
• Study Type: observational
• Target: 1,165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Heart Failure

Keywords

Selara; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant with moderate renal impairment (≥30 mL/min and \<50 mL/min in eCLCr) who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician.

  52 weeks from the start date

Secondary Outcomes (5)

• Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants

  52 weeks from the start date

• The Number of Deaths (Overall Deaths)

  52 weeks from the start date

• The Number of Deaths (Cardiovascular Deaths)

  52 weeks from the start date

• The Overall Mortality Rate

  52 weeks from the start date

• The Cardiovascular-related Mortality Rate

  52 weeks from the start date

Study Arms (1)

Eplerenone

Patients with CHF receiving Selara (eplerenone)

Drug: Eplerenone

Interventions

Eplerenone DRUG

In 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.

Also known as: Selara

Eplerenone

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study

You may qualify if:

• Patients in whom treatment with this drug is for CHF. The indications at approval for this drug are as follows. When using this drug, refer to the latest package insert of this drug.

You may not qualify if:

• Patients who were previously registered for this study. Patients who received eplerenone within the past three months regardless of the reason for use.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

Pfizer Local Country Office

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Eplerenone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 17, 2017
• Study Start: July 5, 2017
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 11, 2023
• Results First Posted: June 28, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)