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Metoprolol in Acute Myocardial Infarction. A PK/PD Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01523054
First received: January 27, 2012
Last updated: January 30, 2012
Last verified: January 2012

January 27, 2012
January 30, 2012
February 2000
April 2002   (final data collection date for primary outcome measure)
  • Pharmacokinetic profile in terms of Cmax, Cmin, AUC [ Time Frame: Treatment duration: 4 days ] [ Designated as safety issue: No ]
    Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses
  • Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded) [ Time Frame: Treatment duration: 4 days ] [ Designated as safety issue: No ]
    Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses
  • Safety profile in terms of adverse events [ Time Frame: Treatment duration: 4 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01523054 on ClinicalTrials.gov Archive Site
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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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Acute Myocardial Infarction
  • 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
  • Experimental: Metoprolol- Toprol XL
    Metoprolol extended release (CR/XL) tablet 200 mg once daily
    Intervention: Drug: Metoprolol- Toprol XL
  • Active Comparator: Metoprolol- Lopressor
    Metoprolol immediate release (IR) tablet
    Intervention: Drug: Metoprolol- Lopressor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
April 2002
April 2002   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01523054
SH-MET-0027
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Dag Elmfeldt, MD, PHD AstraZeneca R&D Mölndal
AstraZeneca
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP