HypertensionPhase 3NCT00255502
307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
A Phase 3 study testing metoprolol succinate in people with Hypertension, run by AstraZeneca at 31 sites in 2 countries.
Trial summary
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Hypertension
- What is being tested?
- metoprolol succinate
- How many people
- 100 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:
- Have successfully completed Protocol 307A, or, or
- Have dropped out of Protocol 307A or failed screening for Protocol 307A for sitting SBP/DBP greater than 20/10 mm Hg over the 95 th percentile using height adjusted charts for age and gender (see Appendices B through E inclusive), or
- Have not enrolled in Protocol 307A but meet all screening criteria for Protocol 307B and are enrolled at sites that have already randomized 6 subjects into Protocol 307A.
- Have the ability to swallow tablets.
Who cannot join
- Have secondary hypertension due to coarctation of aorta, pheochromocytoma, hyperthyroidism or Cushing's syndrome.
- Have a heart rate < 55 beats per minute at Visit 1.
- 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.
- Have a known bleeding, coagulation or platelet disorder that can interfere with blood sampling.
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- 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.
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
Gainesville, Florida
Research Site
Greenville, South Carolina
Research Site
Hartford, Connecticut
Research Site
Honolulu, Hawaii
Research Site
Houston, Texas
Research Site
Lansdale, 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
About this study
Official title: A Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® (Metoprolol Succinate) Extended-release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Open-Label Extension of Protocol 307A
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics 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 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to 16 years old) of both genders. Because response to some therapies in adult hypertension appears to be different in black and non-black populations, the recruitment will have a mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the 13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18) with the exception of those subjects who completed Protocol 307B (16 week open-label treatment).
- 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.
The purpose of this trial is to evaluate the pharmacokinetics and long term safety and
tolerability of metoprolol CR/XL in hypertensive pediatric subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Toprol Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255502
- Sponsor's protocol ID
- D4020C00001
- Other IDs
- 307B
- Status last verified
- Nov 2006
- First submitted
- 17 Nov 2005
- Last updated
- 18 Jan 2020
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® (Metoprolol Succinate) Extended-release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Open-Label Extension of Protocol 307A
- ClinicalTrials.gov ID
- NCT00255502
- Acronym / sponsor ID
- D4020C00001
- Conditions
- Hypertension
- Keywords
- Pediatric hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 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.
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics 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 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to 16 years old) of both genders. Because response to some therapies in adult hypertension appears to be different in black and non-black populations, the recruitment will have a mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the 13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18) with the exception of those subjects who completed Protocol 307B (16 week open-label treatment).
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 (22 listed)
- Have secondary hypertension due to coarctation of aorta, pheochromocytoma, hyperthyroidism or Cushing's syndrome.
- Have a heart rate < 55 beats per minute at Visit 1.
- 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.
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
The purpose of this trial is to evaluate the pharmacokinetics and long term safety and
tolerability of metoprolol CR/XL in hypertensive pediatric subjects.
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 18 Jan 2020.
- 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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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 22 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 18 Jan 2020. 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?
The purpose of this trial is to evaluate the pharmacokinetics and long term safety and. 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?
On the ClinicalTrials.gov record for NCT00255502, 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 18 Jan 2020.