Acute Myocardial InfarctionPhase 1NCT01523054
Metoprolol in Acute Myocardial Infarction. A PK/PD Study
A Phase 1 study testing Metoprolol- Toprol XL and Metoprolol- Lopressor in people with Acute Myocardial Infarction, run by AstraZeneca.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Metoprolol- Toprol XL and Metoprolol- Lopressor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Apr 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or childbearing potential without adequate contraception
- Participation in a clinical study during the last 30 days or previous randomisation in the present study
About this 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
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.
Read the 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
- Conditions
- Acute Myocardial Infarction
- Being tested
- Metoprolol- Toprol XL, Metoprolol- Lopressor
- Keywords
- metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol- Toprol XLDrug
Extended release tablet, 200mg once daily for 4 days
Metoprolol- LopressorDrug
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol- Toprol XL | Experimental | Metoprolol extended release (CR/XL) tablet 200 mg once daily Receives: Drug: Metoprolol- Toprol XL |
| Metoprolol- Lopressor | Active comparator | Metoprolol immediate release (IR) tablet Receives: Drug: Metoprolol- Lopressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Treatment duration: 4 days
Safety profile in terms of adverse events
Measured: Treatment duration: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2000
- Primary completionApr 2002
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dag Elmfeldt, MD, PHD, Study director, AstraZeneca R&D Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523054
- Sponsor's protocol ID
- SH-MET-0027
- Status last verified
- Jan 2012
- First submitted
- 27 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01523054
- Acronym / sponsor ID
- SH-MET-0027
- Conditions
- Acute Myocardial Infarction
- Keywords
- metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol- Toprol XL | Experimental | Drug: Metoprolol- Toprol XLMetoprolol extended release (CR/XL) tablet 200 mg once daily |
| Metoprolol- Lopressor | Active comparator | Drug: Metoprolol- LopressorMetoprolol immediate release (IR) tablet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or childbearing potential without adequate contraception
- Participation in a clinical study during the last 30 days or previous randomisation in the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol- Toprol XLExtended release tablet, 200mg once daily for 4 days | Drug | Metoprolol- Toprol XL |
| Metoprolol- LopressorImmediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily | Drug | Metoprolol- Lopressor |
Primary outcome
Pharmacokinetic profile in terms of Cmax, Cmin, AUC
Time frame: Treatment duration: 4 days
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Elmfeldt, MD, PHD study director
AstraZeneca R&D Mölndal
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metoprolol- Toprol XL and Metoprolol- Lopressor in people with Acute Myocardial Infarction, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile in terms of Cmax, Cmin, AUC (time frame: Treatment duration: 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.