Metoprolol in Acute Myocardial Infarction. A PK/PD Study

NCT ID: NCT01523054

Last Updated: 2012-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2002-04-30

Brief Summary

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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

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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

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metoprolol- Toprol XL

Metoprolol extended release (CR/XL) tablet 200 mg once daily

Group Type EXPERIMENTAL

Metoprolol- Toprol XL

Intervention Type DRUG

Extended release tablet, 200mg once daily for 4 days

Metoprolol- Lopressor

Metoprolol immediate release (IR) tablet

Group Type ACTIVE_COMPARATOR

Metoprolol- Lopressor

Intervention Type DRUG

Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily

Interventions

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Metoprolol- Toprol XL

Extended release tablet, 200mg once daily for 4 days

Intervention Type DRUG

Metoprolol- Lopressor

Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dag Elmfeldt, MD, PHD

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal

Other Identifiers

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SH-MET-0027

Identifier Type: -

Identifier Source: org_study_id

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