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Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (ESSENCE)

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ClinicalTrials.gov Identifier: NCT00749775
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Hypertension Drug: Selara

Study Type : Observational
Actual Enrollment : 3338 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Group/Cohort Intervention/treatment
Eplerenone
Subjects who are treated with Eplerenone tablet for hypertension disease
Drug: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A6141113 prescribes the Selara tablet.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who have been prescribed Selara tablet.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00749775     History of Changes
Other Study ID Numbers: A6141113
First Posted: September 9, 2008    Key Record Dates
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014
Last Verified: November 2013

Keywords provided by Pfizer:
Eplerenone
Selara
Hypertension
Good post-marketing study Practice
Drug use Investigation
Regulatory Post Marketing Commitment Plan
ESSENCE

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents