Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
This study has been completed.
Sponsor:
Orion Corporation, Orion Pharma
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transient Ischemic Attack Stroke |
Drug: Levosimendan Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA. |
Resource links provided by NLM:
Further study details as provided by Orion Corporation, Orion Pharma:
Primary Outcome Measures:
- 24-h Holter reporting [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 32 |
| Study Start Date: | August 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Levosimendan
|
Drug: Levosimendan
from 0.125 mg to 2 mg in escalating doses
|
|
Placebo Comparator: B
Placebo
|
Drug: Placebo
Placebo capsules are identical in appearance to active capsules
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698763
Locations
| Finland | |
| Helsinki University Hospital (HUCH) | |
| Helsinki, Finland | |
| Turku University Hospital (TYKS) | |
| Turku, Finland, 20521 | |
| Germany | |
| Heidelberg University Clinic | |
| Heidelberg, Germany | |
| Hungary | |
| Debrecen University | |
| Debrecen, Hungary | |
| Sweden | |
| Sahlgrenska University Hospital, Dept of Neurology | |
| Gothenburg, Sweden, 413 45 | |
| University Hospital, Neurologmottagningen | |
| Linköping, Sweden, 581 85 | |
| Umeå University Hospital, Strokecenter NVS | |
| Umeå, Sweden, 901 85 | |
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
| Study Director: | Irja Korpela | Orion Corporation, Orion Pharma |
| Principal Investigator: | Risto O. Roine, M.D., Ph.D. | Turku University Hospital |
More Information
No publications provided
| Responsible Party: | Juha Ellmen, Clinical Program Leader, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT00698763 History of Changes |
| Other Study ID Numbers: | 3001088 |
| Study First Received: | June 12, 2008 |
| Last Updated: | November 23, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Orion Corporation, Orion Pharma:
|
An ischaemic cerebrovascular event (stroke or TIA) |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction |
Simendan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cardiotonic Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013