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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
  Purpose

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


Condition Intervention
Hypertension
Drug: Selara

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 3338
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: Selara

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749775

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00749775     History of Changes
Other Study ID Numbers: A6141113
Study First Received: September 5, 2008
Results First Received: November 20, 2013
Last Updated: November 20, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
Cardiovascular Diseases
Vascular Diseases
Eplerenone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014