HypertensionPhase 3NCT00147615

The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years

A Phase 3 study testing Eplerenone in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 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: 140 participants
Where: 21 sitesin 3 countries
Study dates: Oct 2004to Jun 2006
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

Males and females aged 6 to 16 years
The seated 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 4 or 5
Serum or whole blood potassium > 5.5. mEq/L

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

Russia8 sites

Pfizer Investigational Site
Moscow, 117869
Pfizer Investigational Site
Moscow, 119991
Pfizer Investigational Site
Moscow, 127412
Pfizer Investigational Site
Saint Petersburg, 194100
Pfizer Investigational Site
Saint Petersburg, 194291
Pfizer Investigational Site
Saint Petersburg, 196191
Pfizer Investigational Site
Saint Petersburg
Pfizer Investigational Site
Smolensk, 214019

Other trials in Russia

United States7 sites

Pfizer Investigational Site
Columbus, Ohio, 43205-2696
Pfizer Investigational Site
Columbus, Ohio, 43205
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Katy, Texas, 77094
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Park Ridge, Illinois, 60068

Other trials in United States

India6 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560034
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 008
Pfizer Investigational Site
Chennai, 600 031
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Mumbai, 400 012
Pfizer Investigational Site
New Delhi, 110029

Other trials in India

About this study

Official title: Peds II (Pediatric Eplerenone Development Study II)--An Open Label, Long-Term Study To Evaluate The Safety Of Eplerenone In The Treatment Of Hypertension In Children

To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 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.

Safety of eplerenone in hypertensive children

Secondary outcomes (1)

Efficacy and pharmacokinetics 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.

Oct 2004Jun 2006

First posted7 Sep 2005 (estimated)
Study startOct 2004
Study completionJun 2006

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 140 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00147615
Sponsor's protocol ID: A6141077
Status last verified: Dec 2020
First submitted: 2 Sep 2005
Last updated: 22 Dec 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

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 II (Pediatric Eplerenone Development Study II)--An Open Label, Long-Term Study To Evaluate The Safety Of Eplerenone In The Treatment Of Hypertension In Children
ClinicalTrials.gov ID: NCT00147615
Acronym / sponsor ID: A6141077
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2004
Study completion: Jun 2006
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 assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 6 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Males and females aged 6 to 16 years
The seated 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 4 or 5
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

Safety of eplerenone in hypertensive children

1 secondary outcome

Efficacy and pharmacokinetics 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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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

21 sites in 3 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 21 sites in 3 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 21 sites in Russia, United States, India. 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?

Safety of eplerenone in hypertensive children. 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 NCT00147615.

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.