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

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NCT03342690

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Local Country Office
Tokyo, , Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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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)
Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Chronic Heart Failure
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
Eplerenone
Patients with CHF receiving Selara (eplerenone)
Intervention: Drug: Eplerenone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
February 28, 2020
February 28, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03342690
A6141122
No
Not Provided
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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