Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00698763
First received: June 12, 2008
Last updated: November 23, 2009
Last verified: November 2009

June 12, 2008
November 23, 2009
August 2008
April 2009   (final data collection date for primary outcome measure)
24-h Holter reporting [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00698763 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Levosimendan
    Intervention: Drug: Levosimendan
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
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.
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Hungary,   Sweden
 
NCT00698763
3001088
No
Juha Ellmen, Clinical Program Leader, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
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