Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (ESSENCE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00749775|
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||3338 participants|
|Official Title:||Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
- Number of Participants With Treatment Related Adverse Events. [ Time Frame: 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. [ Time Frame: 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.
- Change in Systolic Blood Pressure Over Time. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 12 weeks ]Number of participants among the efficacy analysis population that responded to Selara treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749775
|Study Director:||Pfizer CT.gov Call Center||Pfizer|