HypertensionPhase 4NCT00147563
Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
A Phase 4 study testing Eplerenone in people with Hypertension, run by Pfizer at 1 site in Canada.
Trial summary
To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Eplerenone
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pt with essential hypertension who have never been treated or untreated within the previous 6 months
Who cannot join
- History of Malignant Hypertension
- Sitting diastolic blood pressure > 115mmHg or sitting Systolic blood pressure > 200mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Parallel Design Study to Compare the Effectiveness of Eplerenone Versus Atenolol in Reversing the Remodeling of Resistance Arteries in Subjects With Mild to Moderate Primary Hypertension
To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol.
- Conditions
- Hypertension
- Being tested
- Eplerenone
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline to week 52 in the media/lumen ratio and the maximum % relaxation response to acetylcholine of gluteal subcutaneous resistance vessels, measured from the gluteal biopsy.
Secondary outcomes (1)
Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 34 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147563
- Sponsor's protocol ID
- EPLA-0501-077
- Other IDs
- A6141016
- Status last verified
- May 2007
- First submitted
- 2 Sep 2005
- Last updated
- 15 Apr 2008
- Results posted
- No
Publications
Savoia C, Touyz RM, Amiri F, Schiffrin EL. Selective mineralocorticoid receptor blocker eplerenone reduces resistance artery stiffness in hypertensive patients. Hypertension. 2008 Feb;51(2):432-9. doi: 10.1161/HYPERTENSIONAHA.107.103267. Epub 2008 Jan 14.
PubMed 18195160
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Parallel Design Study to Compare the Effectiveness of Eplerenone Versus Atenolol in Reversing the Remodeling of Resistance Arteries in Subjects With Mild to Moderate Primary Hypertension
- ClinicalTrials.gov ID
- NCT00147563
- Acronym / sponsor ID
- EPLA-0501-077
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- May 2006 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pt with essential hypertension who have never been treated or untreated within the previous 6 months
Key exclusion criteria (2 listed)
- History of Malignant Hypertension
- Sitting diastolic blood pressure > 115mmHg or sitting Systolic blood pressure > 200mmHg
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 |
|---|---|---|
| Eplerenone | Drug | – |
Primary outcome
The change from baseline to week 52 in the media/lumen ratio and the maximum % relaxation response to acetylcholine of gluteal subcutaneous resistance vessels, measured from the gluteal biopsy.
1 secondary outcome
Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
- Derived from this study: PubMed 18195160Savoia C, Touyz RM, Amiri F, Schiffrin EL. Selective mineralocorticoid receptor blocker eplerenone reduces resistance artery stiffness in hypertensive patients. Hypertension. 2008 Feb;51(2):432-9. doi: 10.1161/HYPERTENSIONAHA.107.103267. Epub 2008 Jan 14.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone in people with Hypertension, run by Pfizer at 1 site in Canada.
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 2 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 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change from baseline to week 52 in the media/lumen ratio and the maximum % relaxation response to acetylcholine of gluteal subcutaneous resistance vessels, measured from the gluteal biopsy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147563, which also lists 1 linked publication.
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 15 Apr 2008.