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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.
 
ClinicalTrials.gov Identifier: NCT00698763
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE June 12, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date November 25, 2009
Study Start Date  ICMJE August 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
24-h Holter reporting [ Time Frame: every 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
Official Title  ICMJE Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Transient Ischemic Attack
  • Stroke
Intervention  ICMJE
  • Drug: Levosimendan
    from 0.125 mg to 2 mg in escalating doses
  • Drug: Placebo
    Placebo capsules are identical in appearance to active capsules
Study Arms  ICMJE
  • Experimental: A
    Levosimendan
    Intervention: Drug: Levosimendan
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2009)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
45
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Germany,   Hungary,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698763
Other Study ID Numbers  ICMJE 3001088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juha Ellmen, Clinical Program Leader, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Irja Korpela Orion Corporation, Orion Pharma
Principal Investigator: Risto O. Roine, M.D., Ph.D. Turku University Hospital
PRS Account Orion Corporation, Orion Pharma
Verification Date November 2009

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