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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00749775
First received: September 5, 2008
Last updated: November 20, 2013
Last verified: November 2013

September 5, 2008
November 20, 2013
June 2008
December 2012   (final data collection date for primary outcome measure)
  • 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.
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00749775 on ClinicalTrials.gov Archive Site
  • 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.
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Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness

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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The patients whom an investigator involving A6141113 prescribes the Selara tablet.

Hypertension
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.
Other Name: Selara
Eplerenone
Subjects who are treated with Eplerenone tablet for hypertension disease
Intervention: Drug: Selara
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3338
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who have been prescribed Selara tablet.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00749775
A6141113
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP