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

June 12, 2008
June 17, 2008
November 25, 2009
August 2008
April 2009   (Final data collection date for primary outcome measure)
24-h Holter reporting [ Time Frame: every 2 weeks ]
Same as current
Complete list of historical versions of study NCT00698763 on Archive Site
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Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Transient Ischemic Attack
  • Stroke
  • Drug: Levosimendan
    from 0.125 mg to 2 mg in escalating doses
  • Drug: Placebo
    Placebo capsules are identical in appearance to active capsules
  • Experimental: A
    Intervention: Drug: Levosimendan
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Kivikko M, Kuoppamäki M, Soinne L, Sundberg S, Pohjanjousi P, Ellmen J, Roine RO. Oral Levosimendan Increases Cerebral Blood Flow Velocities in Patients with a History of Stroke or Transient Ischemic Attack: A Pilot Safety Study. Curr Ther Res Clin Exp. 2015 Jan 29;77:46-51. doi: 10.1016/j.curtheres.2015.01.001. eCollection 2015 Dec.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Hungary,   Sweden
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Juha Ellmen, Clinical Program Leader, Orion Pharma
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
Orion Corporation, Orion Pharma
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP