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

• ClinicalTrials.gov Identifier: NCT00749775
• Recruitment Status: Completed
• First Posted: September 9, 2008
• Results First Posted: January 8, 2014
• Last Update Posted: December 22, 2020
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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: December 22, 2020
• 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 ]

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

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

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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2020