Metoprolol in Acute Myocardial Infarction. A PK/PD Study

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.

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Key information

Conditions

Acute Myocardial Infarction

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoprolol- Toprol XL

Drug

Extended release tablet, 200mg once daily for 4 days

Metoprolol- Lopressor

Drug

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

Primary outcomes

Pharmacokinetic profile in terms of Cmax, Cmin, AUC

Time frame: 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)

Time frame: 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

Time frame: Treatment duration: 4 days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2002
Study completion: 2002
First posted: Feb 1, 2012
Registry last updated: Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed