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Adult Trials: 18+ Years
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.
- Severe Kidney Disease
- Hyperkamiemia more than 5.5
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Patient's Management Receiving Eplerenone Therapy | |||
| Official Title | Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist | |||
| Brief Summary | On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:
| |||
| Detailed Description | 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | The following patients may be selected to participate in the survey:
| |||
| Condition | Left Ventricular Dysfunction Post Myocardial Infarction | |||
| Intervention | Other: Prospective Observational
this is an observational study non interventional | |||
| Study Groups/Cohorts | Eplerenone
Intervention: Other: Prospective Observational | |||
| 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 | 160 | |||
| Original Actual Enrollment | 500 | |||
| Actual Study Completion Date | December 2010 | |||
| Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria: The following patients may be selected to participate in the survey:
Exclusion Criteria:
| |||
| Sex/Gender |
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| Ages | 18 Years to 95 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01440049 | |||
| Other Study ID Numbers | NRA6140035 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2018 | |||