Metoprolol in Acute Myocardial Infarction. A PK/PD Study

A Pharmacokinetic and Pharmacodynamic Study Comparing Metoprolol IR and Metoprolol CR/XL Subsequent to Initial Treatment With Intravenous and/or Oral Metoprolol in Patients With Suspected Acut Myocardial Infarction

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01523054

Enrollment

Registered

2012-02-01

Start date

2000-02-29

Completion date

2002-04-30

Last updated

2012-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics

Brief summary

The objective of the study was to compare treatment with two different oral formulations of metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in patients with acute myocardial infarction regarding the following: Pharmacokinetics, peak and trough plasma concentrations and area under the plasma concentration curve. Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open, randomised design with two parallel groups was employed.

Detailed description

A pharmacokinetic and pharmacodynamic study comparing metoprolol IR and metoprolol CR/XL subsequent to initial treatment with intravenous and/or oral metoprolol in patients with suspected acut myocardial infarction

Interventions

DRUGMetoprolol- Toprol XL

Extended release tablet, 200mg once daily for 4 days

DRUGMetoprolol- Lopressor

Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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 until the morning of study day 4 * Sinus rhythm on the day of admission and at randomisation

Exclusion criteria

* Pregnancy or childbearing potential without adequate contraception * Participation in a clinical study during the last 30 days or previous randomisation in the present study

Design outcomes

Primary

Measure	Time frame	Description
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026