Metoprolol in Acute Myocardial Infarction. A PK/PD Study

Acute Myocardial Infarction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523054
• Other study ID #: SH-MET-0027
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2012
• Last updated: January 30, 2012
• Start date: February 2000
• Est. completion date: April 2002

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medicinska fakulteten, Göteborgs universitet, Gothenburg, SwedenNorway: Ullevål Sykehus, Oslo, Norway
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Metoprolol- Toprol XL
Extended release tablet, 200mg once daily for 4 days
• Metoprolol- Lopressor
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile in terms of Cmax, Cmin, AUC	Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses	Treatment duration: 4 days	No
Primary	Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)	Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses	Treatment duration: 4 days	No
Primary	Safety profile in terms of adverse events		Treatment duration: 4 days	Yes