Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Hypertension
• Interventions: Drug: Selara

• Registration Number: NCT00749775
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-11-20
• Results First Submitted QC: 2013-11-20
• Results First Posted: 2014-01-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3338

Inclusion Criteria

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

Exclusion Criteria

• Subjects who have been prescribed Selara tablet.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eplerenone	Selara	Subjects who are treated with Eplerenone tablet for hypertension disease

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Related Adverse Events.	12 weeks	Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.
Number of Participants With Serious Treatment Related Adverse Events.	12 weeks	Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure Over Time.	12 weeks	The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.
Change in Diastolic Blood Pressure Over Time.	12 weeks	The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.
Number of Participants That Responded to Selara Treatment.	12 weeks	Number of participants among the efficacy analysis population that responded to Selara treatment.