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Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

NCT00698763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2009-11-25

No results posted yet for this study

Summary

The primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.

Conditions

  • Transient Ischemic Attack
  • Stroke

Interventions

DRUG

Levosimendan

from 0.125 mg to 2 mg in escalating doses

DRUG

Placebo

Placebo capsules are identical in appearance to active capsules

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Irja Korpela · Orion Corporation, Orion Pharma

  • Risto O. Roine, M.D., Ph.D. · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-04-30
Completion
2009-09-30

Countries

  • Finland
  • Germany
  • Hungary
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00698763 on ClinicalTrials.gov