Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (ESSENCE)
This study has been completed.
Information provided by (Responsible Party):
First received: September 5, 2008
Last updated: November 20, 2013
Last verified: November 2013
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Treatment Related Adverse Events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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:
- Change in Systolic Blood Pressure Over Time. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Number of participants among the efficacy analysis population that responded to Selara treatment.
|Study Start Date:||June 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Subjects who are treated with Eplerenone tablet for hypertension disease
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.
Other Name: Selara
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