HypertensionPhase 3307ANCT00255528

Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects

A Phase 3 study testing metoprolol succinate in people with Hypertension, run by AstraZeneca at 31 sites in 2 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

Who is it for?: Ages 6 to 16 years
Conditions the study is for: Hypertension
What is being tested?: metoprolol succinate
How many people: 144 participants
Where: 31 sitesin 2 countries
Study dates: Jul 2002to not given
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

Male or female between the ages of 6 and 16 years inclusive at the time of screening.
Have a negative urine pregnancy test, if female of childbearing potential.
Have a signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
Have hypertension that is either:
Newly diagnosed and untreated with a mean sitting SBP or DBP above the 95 th percentile on three consecutive office visits, or
Previously diagnosed and currently treated with antihypertensive therapy at Visit 1, then at Visit 3 (off treatment) have a mean sitting SBP or DBP above the 95 th percentile.
Have the ability to swallow tablets.

Who cannot join

Have secondary hypertension due to coarctation of aorta, pheochromocytoma, hyperthyroidism or Cushing's syndrome.
Have SBP or DBP greater than 20 (SBP) or 10 (DBP) mm Hg above the 95th percentile using height adjusted charts for age and gender.
Have a heart rate < 55 beats per minute at randomization.
Have a history of asthma and/or recurring pulmonary disease or infections.
Have a history of cystic fibrosis.
Have a known hypersensitivity reaction to beta-blockers.

Show all 23Show fewer

Have a known bleeding, coagulation or platelet disorder that can interfere with blood sampling.
Have a history of Insulin Dependent Diabetes Mellitus.
Be in any situation or have any condition which, in the opinion of the investigator or sponsor, may interfere with participation in the study or produce a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints.
Have received any investigational agent for any therapeutic reason within 30 days prior to receiving study medication.
Have a clinically significant cardiac valvular disease.
Have a diagnosis of heart failure.
Have clinically significant arrhythmia. This is defined as any arrhythmia requiring medical therapy or that causes symptoms.
Atrioventricular (AV) conduction disturbance, ie, second or third degree AV block.
Be unable or unwilling to comply with the study requirements.
Be non-compliant during the single-blind placebo run-in period of the study as defined by missing three or more doses between study visits.
Have impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than one and one half times the upper limit of the normal range for AST or ALT.
Have a known history of bilateral renal artery stenosis, or unilateral renal artery stenosis to a single kidney. Nephrotic subjects who are not in remission should be excluded.
Be pregnant or breast-feeding an infant.
Currently taking medications known to inhibit CYP2D6, such as quinidine, fluoxetine, paroxetine and propafenone.
Currently taking catecholamine-depleting medications such as reserpine. For any subject who is currently taking medications known to inhibit CYP2D6 or any catecholamine-depleting medication, the sponsor must be contacted to assess feasibility for inclusion into the study.
Currently taking any selective serotonin re-uptake inhibitors (SSRIs) or atypical antipsychotic medication.
Have a history of alcohol or drug abuse, or have a positive urine screen for drugs of abuse or alcohol.

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States30 sites

Research Site
Beaumont, Texas
Research Site
Bellflower, California
Research Site
Beverly Hills, California
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Columbus, Ohio
Research Site
Durham, North Carolina
Research Site
Gainsville, Florida
Research Site
Greenville, South Carolina
Research Site
Hartford, Connecticut
Research Site
Honolulu, Hawaii
Research Site
Houston, Texas
Research Site
Landsdale, Pennsylvania
Research Site
Little Rock, Arkansas
Research Site
Livingston, New Jersey
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Miami, Florida
Research Site
New Hyde Park, New York
Research Site
Norfolk, Virginia
Research Site
Orange, California
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Salt Lake City, Utah
Research Site
San Antonio, Texas
Research Site
Tampa, Florida
Research Site
The Bronx, New York
Research Site
Wilmington, Delaware
Research Site
Winston-Salem, North Carolina

Other trials in United States

Dominican Republic1 site

Research Site
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: Dose Ranging, Safety and Tolerability of TOPROL-XL® (Metoprolol Succinate) Extended-Release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study

This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group study to determine the antihypertensive dose range, efficacy, safety and tolerability of TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. The study population included school age children (age 6 to < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than 50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since response to some therapies in adult hypertension appears to be different in black and non-black populations, recruitment was aimed at a mixture of black and non-black children. The design included a 1-week screening period (for treatment naive subjects), a 1-week single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible subjects were randomized to the double-blind period with a once daily oral dose of metoprolol CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment period.

Conditions: Hypertension
Being tested: metoprolol succinate
Keywords: Pediatric hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

metoprolol succinateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the dose range, safety, and tolerability of metoprolol CR/XL in hypertensive pediatric subjects, based on the change in sitting SBP from baseline to the end of treatment.

Secondary outcomes (2)

Slope of placebo-corrected changes in sitting DBP: baseline to end of treatment as a function of target dose. Differences in mean change: baseline to end of treatment comparing each active group to placebo for sitting SBP and DBP.
Safety profile

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2002?

First posted21 Nov 2005 (estimated)
Study startJul 2002

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 AstraZenecaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 144 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00255528
Sponsor's protocol ID: D4020C00033
Other IDs: 307A, SH-MET-0033
Acronym: 307A
Status last verified: Mar 2007
First submitted: 17 Nov 2005
Last updated: 20 Mar 2007
Results posted: No

Publications

Batisky DL, Sorof JM, Sugg J, Llewellyn M, Klibaner M, Hainer JW, Portman RJ, Falkner B; Toprol-XL Pediatric Hypertension Investigators. Efficacy and safety of extended release metoprolol succinate in hypertensive children 6 to 16 years of age: a clinical trial experience. J Pediatr. 2007 Feb;150(2):134-9, 139.e1. doi: 10.1016/j.jpeds.2006.09.034.
PubMed 17236889

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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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Ranging, Safety and Tolerability of TOPROL-XL® (Metoprolol Succinate) Extended-Release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study
ClinicalTrials.gov ID: NCT00255528
Acronym / sponsor ID: 307A / D4020C00033
Conditions: Hypertension
Keywords: Pediatric hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2002
First posted: 21 Nov 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.

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 (7 listed)

Male or female between the ages of 6 and 16 years inclusive at the time of screening.
Have a negative urine pregnancy test, if female of childbearing potential.
Have a signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
Have hypertension that is either:
Have the ability to swallow tablets.

Key exclusion criteria (23 listed)

Have secondary hypertension due to coarctation of aorta, pheochromocytoma, hyperthyroidism or Cushing's syndrome.
Have SBP or DBP greater than 20 (SBP) or 10 (DBP) mm Hg above the 95th percentile using height adjusted charts for age and gender.
Have a heart rate < 55 beats per minute at randomization.
Have a history of asthma and/or recurring pulmonary disease or infections.
Have a history of cystic fibrosis.

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
metoprolol succinate	Drug	–

Primary outcome

To evaluate the dose range, safety, and tolerability of metoprolol CR/XL in hypertensive pediatric subjects, based on the change in sitting SBP from baseline to the end of treatment.

2 secondary outcomes

Slope of placebo-corrected changes in sitting DBP: baseline to end of treatment as a function of target dose. Differences in mean change: baseline to end of treatment comparing each active group to placebo for sitting SBP and DBP.
Safety profile

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 20 Mar 2007.
Derived from this study: PubMed 17236889Batisky DL, Sorof JM, Sugg J, Llewellyn M, Klibaner M, Hainer JW, Portman RJ, Falkner B; Toprol-XL Pediatric Hypertension Investigators. Efficacy and safety of extended release metoprolol succinate in hypertensive children 6 to 16 years of age: a clinical trial experience. J Pediatr. 2007 Feb;150(2):134-9, 139.e1. doi: 10.1016/j.jpeds.2006.09.034.

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Chronic Kidney Disease, Hypertension (HTN)
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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)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

AstraZeneca Toprol Medical Science Director, MD study director

AstraZeneca

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing metoprolol succinate in people with Hypertension, run by AstraZeneca at 31 sites in 2 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 7 inclusion and 23 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 20 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, 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?

To evaluate the dose range, safety, and tolerability of metoprolol CR/XL in hypertensive pediatric subjects, based on the change in sitting SBP from baseline to the end of treatment.. 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 NCT00255528, 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 20 Mar 2007.