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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.

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

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.
Show all 22Show fewer
  • 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

Other trials in United States

Dominican Republic1 site

  • Research Site

    Santa Domingo

Other trials in Dominican Republic

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.

  1. The purpose of this trial is to evaluate the pharmacokinetics and long term safety and

  2. 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.

  1. First posted21 Nov 2005 (estimated)
  2. Study startJul 2002

Resources

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
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

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.

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