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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 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 31, 2017
First Posted Date November 17, 2017
Last Update Posted Date January 23, 2019
Actual Study Start Date July 5, 2017
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2017)
Percentage of participants with adverse events in participants with moderate renal impairment [ Time Frame: 52 weeks from the start date ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03342690 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 13, 2017)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Recruiting
Estimated Enrollment
 (submitted: November 13, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2020
Estimated Primary Completion Date February 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019