307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
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
2 other identifiers
interventional
100
2 countries
31
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedJanuary 18, 2020
November 1, 2006
November 17, 2005
January 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The purpose of this trial is to evaluate the pharmacokinetics and long term safety and
tolerability of metoprolol CR/XL in hypertensive pediatric subjects.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Little Rock, Arkansas, United States
Research Site
Bellflower, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Hartford, Connecticut, United States
Research Site
Wilmington, Delaware, United States
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Chicago, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Livingston, New Jersey, United States
Research Site
New Hyde Park, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Lansdale, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
Beaumont, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Norfolk, Virginia, United States
Research Site
Santa Domingo, Dominican Republic
Related Publications (1)
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.
PMID: 17236889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Toprol Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 21, 2005
Study Start
July 1, 2002
Last Updated
January 18, 2020
Record last verified: 2006-11