Metoprolol in Acute Myocardial Infarction. A PK/PD Study

January 30, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Metoprolol- Toprol XL
Metoprolol extended release (CR/XL) tablet 200 mg once daily
Drug: Metoprolol- Toprol XL
Extended release tablet, 200mg once daily for 4 days
ACTIVE_COMPARATOR: Metoprolol- Lopressor
Metoprolol immediate release (IR) tablet
Drug: Metoprolol- Lopressor
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Treatment duration: 4 days
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
Treatment duration: 4 days
Safety profile in terms of adverse events
Time Frame: Treatment duration: 4 days
Treatment duration: 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Dag Elmfeldt, MD, PHD, AstraZeneca R&D Mölndal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (ACTUAL)

April 1, 2002

Study Completion (ACTUAL)

April 1, 2002

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-MET-0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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