Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

NCT ID: NCT00698763

Last Updated: 2009-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-09-30

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 evaluation of proarrhythmic potential of the different dose regimens.

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.

Conditions

Transient Ischemic Attack; Stroke

Keywords

An ischaemic cerebrovascular event (stroke or TIA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Levosimendan

Group Type: EXPERIMENTAL

Levosimendan

Intervention Type: DRUG

from 0.125 mg to 2 mg in escalating doses

B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules are identical in appearance to active capsules

Interventions

Levosimendan

from 0.125 mg to 2 mg in escalating doses

Intervention Type: DRUG

Placebo

Placebo capsules are identical in appearance to active capsules

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Orion Pharma

Principal Investigators

Irja Korpela

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Risto O. Roine, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Helsinki University Hospital (HUCH)

Helsinki, , Finland

Turku University Hospital (TYKS)

Turku, , Finland

Heidelberg University Clinic

Heidelberg, , Germany

Debrecen University

Debrecen, , Hungary

Sahlgrenska University Hospital, Dept of Neurology

Gothenburg, , Sweden

University Hospital, Neurologmottagningen

Linköping, , Sweden

Umeå University Hospital, Strokecenter NVS

Umeå, , Sweden

Countries

Finland; Germany; Hungary; Sweden

References

Kivikko M, Kuoppamaki M, Soinne L, Sundberg S, Pohjanjousi P, Ellmen J, Roine RO. Oral Levosimendan Increases Cerebral Blood Flow Velocities in Patients with a History of Stroke or Transient Ischemic Attack: A Pilot Safety Study. Curr Ther Res Clin Exp. 2015 Jan 29;77:46-51. doi: 10.1016/j.curtheres.2015.01.001. eCollection 2015 Dec.

Reference Type: DERIVED

PMID: 26082815 (View on PubMed)

Other Identifiers

3001088

Identifier Type: -

Identifier Source: org_study_id