Status:
COMPLETED
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Transient Ischemic Attack
Stroke
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 ev...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00698763
Start Date
August 1 2008
End Date
September 1 2009
Last Update
November 25 2009
Active Locations (7)
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1
Helsinki University Hospital (HUCH)
Helsinki, Finland
2
Turku University Hospital (TYKS)
Turku, Finland, 20521
3
Heidelberg University Clinic
Heidelberg, Germany
4
Debrecen University
Debrecen, Hungary