HypertensionPhase 3NCT00147589
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.
A Phase 3 study testing Eplerenone in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 41 sites in 5 countries.
Trial summary
To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Eplerenone
- How many people
- 320 participants
- Where
- 41 sitesin 5 countries
- Study dates
- Sep 2004to Jan 2007
- Phase
- Phase 3
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-16 years old male and female
- Systolic blood pressure greater than or equal to the 95th percentile for age, gender, and height, measured on at least 3 separate occasions
Who cannot join
- K/DOQI classification of stages of chronic kidney disease equal to or greater than 3
- Serum or whole blood potassium > 5.5 mEq/L
Trial locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
United States28 sites
Pfizer Investigational Site
Ann Arbor, Michigan
Pfizer Investigational Site
Augusta, Georgia
Pfizer Investigational Site
Beaumont, Texas
Pfizer Investigational Site
Beverly Hills, California
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Carrboro, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina
Pfizer Investigational Site
Cleveland, Ohio
Pfizer Investigational Site
Columbus, Ohio
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Inglewood, California
Pfizer Investigational Site
Jackson, Mississippi
Pfizer Investigational Site
Jacksonville, Florida
Pfizer Investigational Site
Katy, Texas
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Livingston, New Jersey
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Louisville, Kentucky
Pfizer Investigational Site
Memphis, Tennessee
Pfizer Investigational Site
Miami, Florida
Pfizer Investigational Site
Park Ridge, Illinois
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Pittsboro, North Carolina
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Shreveport, Louisiana
Pfizer Investigational Site
Tulsa, Oklahoma
Pfizer Investigational Site
Tupelo, Mississippi
Pfizer Investigational Site
Youngstown, Ohio
South Africa7 sites
Pfizer Investigational Site
Cape Town
Pfizer Investigational Site
Capital Park, Gauteng
Pfizer Investigational Site
Johannesburg, Gauteng
Pfizer Investigational Site
Parow, Western Cape
Pfizer Investigational Site
Polokwane, Lipompo Province
Pfizer Investigational Site
Pretoria, Gauteng
Pfizer Investigational Site
Soweto, Gauteng
Russia3 sites
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Saint Petersburg
Pfizer Investigational Site
Smolensk
India2 sites
Pfizer Investigational Site
Bangalore, Karnataka
Pfizer Investigational Site
Chennai, Tamil Nadu
Dominican Republic1 site
Pfizer Investigational Site
Santo Domingo, DN
About this study
Official title: Peds I (Pediatric Eplerenone Development Study I): A Randomized, Double-Blind, Placebo Withdrawal, Parallel Group, Dose-Response Study To Evaluate The Efficacy And Safety Of Eplerenone In The Treatment Of Hypertension In Children
To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.
- 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.
Efficacy of eplerenone in children
Secondary outcomes (1)
Safety and tolerability of eplerenone in hypertensive children
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 startSep 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 320 participants
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
- NCT00147589
- Sponsor's protocol ID
- A6141001
- Status last verified
- Dec 2020
- First submitted
- 2 Sep 2005
- Last updated
- 22 Dec 2020
- Results posted
- 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
- Peds I (Pediatric Eplerenone Development Study I): A Randomized, Double-Blind, Placebo Withdrawal, Parallel Group, Dose-Response Study To Evaluate The Efficacy And Safety Of Eplerenone In The Treatment Of Hypertension In Children
- ClinicalTrials.gov ID
- NCT00147589
- Acronym / sponsor ID
- A6141001
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Jan 2007 (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 evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-16 years old male and female
- Systolic blood pressure greater than or equal to the 95th percentile for age, gender, and height, measured on at least 3 separate occasions
Key exclusion criteria (2 listed)
- K/DOQI classification of stages of chronic kidney disease equal to or greater than 3
- Serum or whole blood potassium > 5.5 mEq/L
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
Efficacy of eplerenone in children
1 secondary outcome
Safety and tolerability of eplerenone in hypertensive children
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 22 Dec 2020.
- 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
41 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eplerenone in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 41 sites in 5 countries.
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 2 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, South Africa, Russia, India, Dominican Republic. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of eplerenone in children. 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.