Metoprolol in Acute Myocardial Infarction. A PK/PD Study

Phase 1

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Metoprolol- Lopressor; Drug: Metoprolol- Toprol XL

• Registration Number: NCT01523054
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Status Verified: 2012-01
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-30
• Last Update Submitted: 2012-01-30
• Study First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoprolol- Lopressor	Metoprolol- Lopressor	Metoprolol immediate release (IR) tablet
Metoprolol- Toprol XL	Metoprolol- Toprol XL	Metoprolol extended release (CR/XL) tablet 200 mg once daily

Primary Outcome Measures

Name	Time	Method
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