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 23, 2019
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
| 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
| Group/Cohort | Intervention/treatment |
|---|---|
|
Eplerenone
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 |
Primary Outcome Measures :
- Percentage of participants with adverse events in participants with moderate renal impairment [ Time Frame: 52 weeks from the start date ]
Secondary Outcome Measures :
- Percentage of subjects with adverse event in participants [ Time Frame: 52 weeks from the start date ]
- The number of deaths (Overall mortality) [ Time Frame: 52 weeks from the start date ]
- The number of deaths (Cardiovascular deaths) [ Time Frame: 52 weeks from the start date ]
- The percentage of death (Overall mortality) [ Time Frame: 52 weeks from the start date ]
- The percentage of death (Cardiovascular deaths) [ Time Frame: 52 weeks from the start date ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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
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.
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
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
| Japan | |
| Pfizer Local Country Office | Recruiting |
| Tokyo, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 23, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (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/data_requests. |
Keywords provided by Pfizer:
|
Selara Chronic Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Eplerenone Mineralocorticoid Receptor Antagonists Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Antihypertensive Agents |