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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00255528
Other study ID # D4020C00033
Secondary ID 307ASH-MET-0033
Status Completed
Phase Phase 3
First received November 17, 2005
Last updated March 19, 2007
Start date July 2002

Study information

Verified date March 2007
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 16 Years
Eligibility 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:

1. Newly diagnosed and untreated with a mean sitting SBP or DBP above the 95 th percentile on three consecutive office visits, or

2. 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.

Exclusion Criteria:

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
metoprolol succinate


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary Safety profile
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