HypertensionESSENCENCT00749775
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
An observational study of Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Selara
- Type of treatment
- Pill or oral medicine
- How many people
- 3,338 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A6141113 prescribes the Selara tablet.
Who may be able to join
- Male or Female patients who are prescribed Selara tablet for Hypertension.
Who cannot join
- Subjects who have been prescribed Selara tablet.
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Selara
- Keywords
- Eplerenone, Selara, Hypertension, Good post-marketing study Practice, Drug use Investigation, Regulatory Post Marketing Commitment Plan, ESSENCE
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelaraDrug
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 group | Role | What they receive |
|---|---|---|
| Eplerenone | Subjects who are treated with Eplerenone tablet for hypertension disease Receives: Drug: Selara |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Related Adverse Events.
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.
Measured: 12 weeks
Number of Participants With Serious Treatment Related Adverse Events.
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.
Measured: 12 weeks
Secondary outcomes (3)
Change in Systolic Blood Pressure Over Time.
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.
Measured: 12 weeks
Change in Diastolic Blood Pressure Over Time.
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.
Measured: 12 weeks
Number of Participants That Responded to Selara Treatment.
Number of participants among the efficacy analysis population that responded to Selara treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749775
- Sponsor's protocol ID
- A6141113
- Acronym
- ESSENCE
- Status last verified
- Dec 2020
- First submitted
- 5 Sep 2008
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness
- ClinicalTrials.gov ID
- NCT00749775
- Acronym / sponsor ID
- ESSENCE / A6141113
- Conditions
- Hypertension
- Keywords
- Eplerenone, Selara, Hypertension, Good post-marketing study Practice, Drug use Investigation, Regulatory Post Marketing Commitment Plan, ESSENCE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,338 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 8 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eplerenone | – | Drug: SelaraSubjects who are treated with Eplerenone tablet for hypertension disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A6141113 prescribes the Selara tablet.
Key inclusion criteria (1 listed)
- Male or Female patients who are prescribed Selara tablet for Hypertension.
Key exclusion criteria (1 listed)
- Subjects who have been prescribed Selara tablet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelaraTreatment 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. | Drug | Eplerenone |
Primary outcome
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.
3 secondary outcomes
Change in Systolic Blood Pressure Over Time.
Time frame: 12 weeks
Change in Diastolic Blood Pressure Over Time.
Time frame: 12 weeks
Number of Participants That Responded to Selara Treatment.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Related Adverse Events. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.