Recent Updates
Recently added Catalysts

Metoprolol- Toprol XL

Phase 1

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

Metoprolol- Toprol XL development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Metoprolol- Toprol XL clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Frequently asked questions about Metoprolol- Toprol XL

What is Metoprolol-Toprol XL used for?

Metoprolol-Toprol XL is being studied for use in acute myocardial infarction, commonly known as a heart attack. The clinical development program in this indication is at Phase 1, with one completed pharmacokinetic and pharmacodynamic study conducted in patients with acute myocardial infarction.

Who makes Metoprolol-Toprol XL?

AstraZeneca PLC, which trades under the ticker AZN, is the developer associated with Metoprolol-Toprol XL. The company is listed as the sponsor of the Phase 1 pharmacokinetic and pharmacodynamic study of the drug in acute myocardial infarction.

What phase is Metoprolol-Toprol XL in?

Metoprolol-Toprol XL is in Phase 1 development for acute myocardial infarction. One Phase 1 trial has been completed, and no trials are currently active. The program is investigational and has not been approved for this indication based on the available development information.

What clinical trials is Metoprolol-Toprol XL in?

Metoprolol-Toprol XL has been evaluated in one completed Phase 1 trial, NCT01523054, titled Metoprolol in Acute Myocardial Infarction. A PK/PD Study. The trial enrolled 27 patients, was randomized, used an active control, and was not double blind.

How does Metoprolol-Toprol XL work?

Metoprolol-Toprol XL is a small molecule. It was evaluated in a Phase 1 pharmacokinetic and pharmacodynamic study in patients with acute myocardial infarction, a study design used to characterize how the body processes the drug and how the drug affects the body.