Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)
NCT03342690
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Adult Trials: 18+ Years
- 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.
- Patients who were previously registered for this study. Patients who received
eplerenone within the past three months regardless of the reason for use.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) | ||||
| Official Title | DRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE) | ||||
| Brief 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. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Chronic Heart Failure | ||||
| Intervention | 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 | ||||
| Study Groups/Cohorts | Eplerenone
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 Status | Completed | ||||
| Actual Enrollment | 1165 | ||||
| Original Estimated Enrollment | 1000 | ||||
| Actual Study Completion Date | July 15, 2020 | ||||
| Actual Primary Completion Date | July 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03342690 | ||||
| Other Study ID Numbers | A6141122 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | August 2020 | ||||