A Phase 1 interventional study of Metoprolol- Toprol XL and Metoprolol- Lopressor in Acute Myocardial Infarction, sponsored by AstraZeneca. Completed. Per ClinicalTrials.gov, last updated 2012-02-01.
Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science
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.
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
AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
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Metoprolol extended release (CR/XL) tablet 200 mg once daily
Drug: Metoprolol- Toprol XL
Metoprolol immediate release (IR) tablet
Drug: Metoprolol- Lopressor
Extended release tablet, 200mg once daily for 4 days
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
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
Time frame: 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
Time frame: Treatment duration: 4 days
Safety profile in terms of adverse events
Time frame: Treatment duration: 4 days
No study locations are listed for this record.
The record gives a start of Feb 2000, a primary completion of Apr 2002 and a completion of Apr 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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