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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Stroke
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 23, 2014