Trial intelligence / Profile preview

CASTEMI: Caldaret in STEMI Patients Undergoing PCI

NCT00078013Phase 2

Key facts

Status
Completed
Start
Apr 2003
Countries
1
Modality
Small Molecules
Conditions
ST elevation myocardial infarction (STEMI)
01

Overview

Phase 2, randomised, double-blind trial of Caldaret in ST elevation myocardial infarction (STEMI) (3 arms), sponsored by Mitsubishi Tanabe Pharma Corporation. Primary endpoints: Final infarct size measured by single photon emission computed tomography (SPECT) at Day 180, Safety at Day 180 and 1 more. Started Apr 2003; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Group A

    MCC-135 4.5 mg/kg/48 hours

  • Group B

    MCC-135 9.0 mg/kg/48 hours

  • Group C

    Placebo/48 hours

03

Endpoints

Primary

  • Final infarct size measured by single photon emission computed tomography (SPECT)

  • Safety

  • Tolerability

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