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: February 20, 2013
Last verified: February 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:
- Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Systolic Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|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
Contacts and Locations