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Patient's Management Receiving Eplerenone Therapy

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NCT01440049

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Left Ventricular Dysfunction Post Myocardial Infarction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-95 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Severe Kidney Disease

- Hyperkamiemia more than 5.5

NCT01440049
Pfizer
Completed
Patient's Management Receiving Eplerenone Therapy

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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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Left Ventricular Dysfunction Post Myocardial Infarction
Other: Prospective Observational
this is an observational study non interventional
Eplerenone
Intervention: Other: Prospective Observational
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01440049
NRA6140035
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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