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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Metoprolol- Toprol XL
Drug: Metoprolol- Lopressor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: February 2000
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metoprolol- Toprol XL
Metoprolol extended release (CR/XL) tablet 200 mg once daily
Drug: Metoprolol- Toprol XL
Extended release tablet, 200mg once daily for 4 days
Active Comparator: Metoprolol- Lopressor
Metoprolol immediate release (IR) tablet
Drug: Metoprolol- Lopressor
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523054

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dag Elmfeldt, MD, PHD AstraZeneca R&D Mölndal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01523054     History of Changes
Other Study ID Numbers: SH-MET-0027
Study First Received: January 27, 2012
Last Updated: January 30, 2012
Health Authority: Sweden: Medicinska fakulteten, Göteborgs universitet, Gothenburg, Sweden
Norway: Ullevål Sykehus, Oslo, Norway

Keywords provided by AstraZeneca:
metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014