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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03342690
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

Condition or disease Intervention/treatment
Chronic Heart Failure Drug: Eplerenone

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.

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Selara(Registered). Tablets(an Investigation For Chronic Heart Failure)
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Eplerenone
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients with CHF receiving Selara (eplerenone)
Drug: Eplerenone

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.

Other Name: Selara

Outcome Measures

Primary Outcome Measures :
  1. Percentage of participants with adverse events in participants with moderate renal impairment [ Time Frame: 52 weeks from the start date ]

Secondary Outcome Measures :
  1. Percentage of subjects with adverse event in participants [ Time Frame: 52 weeks from the start date ]
  2. The number of deaths (Overall mortality) [ Time Frame: 52 weeks from the start date ]
  3. The number of deaths (Cardiovascular deaths) [ Time Frame: 52 weeks from the start date ]
  4. The percentage of death (Overall mortality) [ Time Frame: 52 weeks from the start date ]
  5. The percentage of death (Cardiovascular deaths) [ Time Frame: 52 weeks from the start date ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342690

Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer Local Country Office Recruiting
Tokyo, Japan
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03342690     History of Changes
Other Study ID Numbers: A6141122
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents