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Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

NCT ID: NCT00749775

Last Updated: 2020-12-22

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

3338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-12-31

Brief Summary

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To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.

Detailed Description

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Conditions

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Hypertension

Keywords

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Eplerenone Selara Hypertension Good post-marketing study Practice Drug use Investigation Regulatory Post Marketing Commitment Plan ESSENCE

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Eplerenone

Subjects who are treated with Eplerenone tablet for hypertension disease

Selara

Intervention Type DRUG

Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Selara may be administered with or without food.

Interventions

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Selara

Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Selara may be administered with or without food.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or Female patients who are prescribed Selara tablet for Hypertension.

Exclusion Criteria

* Subjects who have been prescribed Selara tablet.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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=A6141113&StudyName=Selara%20Drug%20use%20Investigation%20%28Regulatory%20Post%20Marketing%20Commitment%20Plan%29%20%20

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Other Identifiers

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A6141113

Identifier Type: -

Identifier Source: org_study_id