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Trial record 60 of 112 for:    EPLERENONE

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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 5, 2008
First Posted Date September 9, 2008
Results First Submitted Date November 20, 2013
Results First Posted Date January 8, 2014
Last Update Posted Date January 8, 2014
Study Start Date June 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2013)
  • 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.
Original Primary Outcome Measures
 (submitted: September 5, 2008)
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 12 weeks ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 12 weeks ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00749775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 20, 2013)
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness
Brief Summary To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A6141113 prescribes the Selara tablet.
Condition Hypertension
Intervention 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.
Study Groups/Cohorts Eplerenone
Subjects who are treated with Eplerenone tablet for hypertension disease
Intervention: Drug: Selara
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2013)
3338
Original Estimated Enrollment
 (submitted: September 5, 2008)
3000
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who have been prescribed Selara tablet.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00749775
Other Study ID Numbers A6141113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2013