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Metoprolol in Acute Myocardial Infarction. A PK/PD Study

NCT01523054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2012-02-01

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Metoprolol- Toprol XL

Extended release tablet, 200mg once daily for 4 days

DRUG

Metoprolol- Lopressor

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

Sponsors & Collaborators

Principal Investigators

  • Dag Elmfeldt, MD, PHD · AstraZeneca R&D Mölndal

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2002-04-30
Completion
2002-04-30

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523054 on ClinicalTrials.gov