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Metoprolol in Acute Myocardial Infarction. A PK/PD Study

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myocardial Infarction

Intervention: Metoprolol- Toprol XL (Drug); Metoprolol- Lopressor (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Dag Elmfeldt, MD, PHD, Study Director, Affiliation: AstraZeneca R&D Mölndal

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.

Clinical Details

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

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

Primary outcome:

Pharmacokinetic profile in terms of Cmax, Cmin, AUC

Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)

Safety profile in terms of adverse events

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: February 2000
Last updated: January 30, 2012

Page last updated: August 23, 2015

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