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Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables (Electro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698763
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : November 25, 2009
Information provided by:
Orion Corporation, Orion Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Transient Ischemic Attack Stroke Drug: Levosimendan Drug: Placebo Phase 2

Detailed Description:
This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. The study population will be randomly allocated either to the levosimendan group or to the placebo group. The double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). Each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.
Study Start Date : August 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: A
Drug: Levosimendan
from 0.125 mg to 2 mg in escalating doses

Placebo Comparator: B
Drug: Placebo
Placebo capsules are identical in appearance to active capsules

Primary Outcome Measures :
  1. 24-h Holter reporting [ Time Frame: every 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit.

Exclusion Criteria:

  • Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection
  • Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period
  • History of life-threatening ventricular arrhythmia within 3 months.
  • History of Torsades de Pointes (TdP) or family history of long QT-syndrome
  • Heart rate (HR) < 50 or > 100 bpm.
  • Systolic blood pressure (SBP) < 100 mmHg or > 180 mmHg, or diastolic blood pressure (DBP) > 100 mmHg.
  • Ventricular tachycardia.
  • Episode of atrial fibrillation or atrial flutter lasting > 60 seconds.
  • Second or third degree atrioventricular (AV) block.
  • Potassium (K) < 3.7 mmol/l or > 5.5 mmol/l.
  • Creatinine > 170 µmol/l or on dialysis.
  • Blood haemoglobin <10 g/dl; clinically significant hepatic impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698763

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Helsinki University Hospital (HUCH)
Helsinki, Finland
Turku University Hospital (TYKS)
Turku, Finland, 20521
Heidelberg University Clinic
Heidelberg, Germany
Debrecen University
Debrecen, Hungary
Sahlgrenska University Hospital, Dept of Neurology
Gothenburg, Sweden, 413 45
University Hospital, Neurologmottagningen
Linköping, Sweden, 581 85
Umeå University Hospital, Strokecenter NVS
Umeå, Sweden, 901 85
Sponsors and Collaborators
Orion Corporation, Orion Pharma
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Study Director: Irja Korpela Orion Corporation, Orion Pharma
Principal Investigator: Risto O. Roine, M.D., Ph.D. Turku University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Juha Ellmen, Clinical Program Leader, Orion Pharma Identifier: NCT00698763    
Other Study ID Numbers: 3001088
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by Orion Corporation, Orion Pharma:
An ischaemic cerebrovascular event (stroke or TIA)
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs