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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- AstraZeneca
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The purpose of this trial is to evaluate the pharmacokinetics and long term safety and
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Have secondary hypertension due to coarctation of aorta, pheochromocytoma, hyperthyroidism or Cushing's syndrome.
- •Have a heart rate \< 55 beats per minute at Visit
- •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.
Outcomes
Primary Outcomes
The purpose of this trial is to evaluate the pharmacokinetics and long term safety and
tolerability of metoprolol CR/XL in hypertensive pediatric subjects.