Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Simendan

Criteria

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.