Metoprolol in Acute Myocardial Infarction. A PK/PD Study
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
1 other identifier
interventional
27
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2000
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 27, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedFebruary 1, 2012
January 1, 2012
2.2 years
January 27, 2012
January 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Safety profile in terms of adverse events
Treatment duration: 4 days
Study Arms (2)
Metoprolol- Toprol XL
EXPERIMENTALMetoprolol extended release (CR/XL) tablet 200 mg once daily
Metoprolol- Lopressor
ACTIVE COMPARATORMetoprolol immediate release (IR) tablet
Interventions
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or childbearing potential without adequate contraception
- Participation in a clinical study during the last 30 days or previous randomisation in the present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dag Elmfeldt, MD, PHD
AstraZeneca R&D Mölndal
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2012
First Posted
February 1, 2012
Study Start
February 1, 2000
Primary Completion
April 1, 2002
Study Completion
April 1, 2002
Last Updated
February 1, 2012
Record last verified: 2012-01