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Metoprolol- Toprol XL

Phase 1

Acute Myocardial Infarction | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Feb 1, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Metoprolol- Toprol XL · 1 trial · 1 indication

Phase 1 1
NCT01523054Metoprolol in Acute Myocardial Infarction. A PK/PD StudyAcute Myocardial Infarction
COMPLETED27 Analytics
PHASE1COMPLETED
Metoprolol in Acute Myocardial Infarction. A PK/PD Study
Acute Myocardial InfarctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic profile in terms of Cmax, Cmin, AUC
Treatment duration: 4 days

Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses

Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)
Treatment duration: 4 days

Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses

Safety profile in terms of adverse events
Treatment duration: 4 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Metoprolol- Toprol XLEXPERIMENTALMetoprolol extended release (CR/XL) tablet 200 mg once daily
Metoprolol- LopressorACTIVE_COMPARATORMetoprolol immediate release (IR) tablet

Interventions

NameTypeDescription
Metoprolol- Toprol XLDRUGExtended release tablet, 200mg once daily for 4 days
Metoprolol- LopressorDRUGImmediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
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Eligibility Criteria

SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male and female patients admitted to the CCU with suspected acute myocardial infarction * Age 18 years or older * Treated with and tolerated the full dose of metoprolol IR 50 mr four times daily or metoprolol CR/XL 200 mg once daily on study day 1 * Expected to stay in the CCU...

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