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CLINICAL TRIALS PROFILE FOR TOPROL-XL

Clinical Trials for Toprol-xl

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00038077	Reversal of Ventricular Remodeling With Toprol-XL	Completed	AstraZeneca	Phase 3	The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.
NCT00123903	COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria	Terminated	GlaxoSmithKline	Phase 3	This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.
NCT00241904	Reducing Total Cardiovascular Risk in an Urban Community	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER. The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.
NCT00241904	Reducing Total Cardiovascular Risk in an Urban Community	Completed	Johns Hopkins University	N/A	PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER. The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.
NCT00255502	307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects	Completed	AstraZeneca	Phase 3	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).
NCT00255528	Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects	Completed	AstraZeneca	Phase 3	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.
Trial ID	Title	Status	Sponsor	Phase	Summary