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Patient's Management Receiving Eplerenone Therapy

NCT ID: NCT01440049

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:

* To describe the characteristics of the population treated.
* To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations).
* To describe the follow-up methods of the treatment.
* To describe the possible interruptions of the treatment

Detailed Description

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A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.

Conditions

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Left Ventricular Dysfunction Post Myocardial Infarction

Keywords

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patients with MI- on top of treatment add Eplerenone - assess LVEF and BP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eplerenone

Prospective Observational

Intervention Type OTHER

this is an observational study non interventional

Interventions

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Prospective Observational

this is an observational study non interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

The following patients may be selected to participate in the survey:

* Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date.
* Those likely to be followed by the same physician for a minimal period of twelve months.

Exclusion Criteria

* Severe Kidney Disease
* Hyperkamiemia more than 5.5
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NRA6140035&StudyName=Assessment%20Of%20Follow-Up%20Methods%20For%20Patients%20Treated%20In%20The%20Long-Term%20With%20A%20Specific%20Aldosterone%20Receptor%20Antagonist

To obtain contact information for a study center near you, click here.

Other Identifiers

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NRA6140035

Identifier Type: -

Identifier Source: org_study_id