Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables - Full Text View

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00698763

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 II

MedlinePlus related topics: Transient Ischemic Attack

Drug Information available for: Simendan Levosimendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.

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 ]

Estimated Enrollment:	45
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Levosimendan	Drug: Levosimendan from 0.125 mg to 2 mg in escalating doses
B: Placebo Comparator 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

Contacts

Contact: Irja Korpela

+358 10 426 7142

irja.korpela@orionpharma.com

Locations

Finland
Turku University Hospital (TYKS)	Recruiting
Turku, Finland, 20521
Contact: Risto O. Roine, M.D., Ph.D.
Principal Investigator: Risto O. Roine, M.D. , Ph.D.
Helsinki University Hospital (HUCH)	Not yet recruiting
Helsinki, Finland
Contact: Lauri Soinne, Dr
Principal Investigator: Lauri Soinne, Dr
Germany
Heidelberg University Clinic	Not yet recruiting
Heidelberg, Germany
Contact: Thorsten Steiner, Prof. Dr.
Principal Investigator: Thorsten Steiner, Prof. Dr.
Hungary
Debrecen University	Not yet recruiting
Debrecen, Hungary
Contact: Laszlo Csiba, Dr
Principal Investigator: Laszlo Csiba, Dr
Sweden
University Hospital, Neurologmottagningen	Not yet recruiting
Linköping, Sweden, 581 85
Contact: Margarita Callander, Dr
Principal Investigator: Margarita Callander, Dr
Umeå University Hospital, Strokecenter NVS	Recruiting
Umeå, Sweden, 901 85
Contact: Per Wester, Dr
Principal Investigator: Per Wester, Dr
Sahlgrenska University Hospital, Dept of Neurology	Not yet recruiting
Gothenburg, Sweden, 413 45
Contact: Jan-Erik Karlsson, Dr
Principal Investigator: Jan-Erik Karlsson, Dr

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:	Orion Pharma ( Juha Ellmen, Clinical Program Leader )
Study ID Numbers:	3001088
Study First Received:	June 12, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00698763 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Orion Corporation, Orion Pharma:

An ischaemic cerebrovascular event (stroke or TIA)

Study placed in the following topic categories:

Ischemic Attack, Transient
Vasodilator Agents
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia

Cardiovascular Agents
Brain Diseases
Cerebrovascular Disorders
Simendan
Phosphodiesterase Inhibitors
Brain Ischemia
Anti-Arrhythmia Agents

Additional relevant MeSH terms:

Ischemic Attack, Transient
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents

Brain Diseases
Protective Agents
Cerebrovascular Disorders
Pharmacologic Actions
Simendan
Phosphodiesterase Inhibitors
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 07, 2009