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Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Last updated on October 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who have been prescribed Selara tablet.

NCT00749775
Pfizer
Completed
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief TitleSelara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleEplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness
Brief SummaryTo collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A6141113 prescribes the Selara tablet.
ConditionHypertension
InterventionDrug: 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/CohortsEplerenone
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 StatusCompleted
Actual Enrollment
 (submitted: February 20, 2013)
3338
Original Estimated Enrollment
 (submitted: September 5, 2008)
3000
Actual Study Completion DateDecember 2012
Actual Primary Completion DateDecember 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00749775
Other Study ID NumbersA6141113
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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