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

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Local Country Office
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT03342690
Pfizer
Recruiting
Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)

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Chronic Heart Failure
NCT03342690
All Genders
0+
Years
Tokyo,
Descriptive Information
Brief TitleDrug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)
Official TitleDRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE)
Brief SummarySecondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
Detailed DescriptionThis 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe 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
ConditionChronic Heart Failure
InterventionDrug: 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
Study Groups/CohortsEplerenone
Patients with CHF receiving Selara (eplerenone)
Intervention: Drug: Eplerenone
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: November 13, 2017)
1000
Original Estimated EnrollmentSame as current
Estimated Study Completion DateFebruary 28, 2020
Estimated Primary Completion DateFebruary 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03342690
Other Study ID NumbersA6141122
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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