Metoprolol in Acute Myocardial Infarction. A PK/PD Study

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metoprolol

Criteria

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