Back to resultsMetoprolol in Acute Myocardial Infarction. A PK/PD Study
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Metoprolol- Toprol XL
Metoprolol- Lopressor
Sponsored by
About this trial
This is an interventional basic science trial for Acute Myocardial Infarction focused on measuring metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metoprolol- Toprol XL
Metoprolol- Lopressor
Arm Description
Metoprolol extended release (CR/XL) tablet 200 mg once daily
Metoprolol immediate release (IR) tablet
Outcomes
Primary Outcome Measures
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
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
Safety profile in terms of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01523054
Brief Title
Metoprolol in Acute Myocardial Infarction. A PK/PD Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
April 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metoprolol- Toprol XL
Arm Type
Experimental
Arm Description
Metoprolol extended release (CR/XL) tablet 200 mg once daily
Arm Title
Metoprolol- Lopressor
Arm Type
Active Comparator
Arm Description
Metoprolol immediate release (IR) tablet
Intervention Type
Drug
Intervention Name(s)
Metoprolol- Toprol XL
Intervention Description
Extended release tablet, 200mg once daily for 4 days
Intervention Type
Drug
Intervention Name(s)
Metoprolol- Lopressor
Intervention Description
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
Primary Outcome Measure Information:
Title
Pharmacokinetic profile in terms of Cmax, Cmin, AUC
Description
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
Title
Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)
Description
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
Title
Safety profile in terms of adverse events
Time Frame
Treatment duration: 4 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Elmfeldt, MD, PHD
Organizational Affiliation
AstraZeneca R&D Mölndal
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Metoprolol in Acute Myocardial Infarction. A PK/PD Study
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