Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables "Electro"

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • Placebo Drug
    Intervention Desc: Placebo capsules are identical in appearance to active capsules
    ARM 1: Kind: Experimental
    Label: B
    Description: Placebo
  • Levosimendan Drug
    Intervention Desc: from 0.125 mg to 2 mg in escalating doses
    ARM 1: Kind: Experimental
    Label: A
    Description: Levosimendan

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 24-h Holter reporting every 2 weeks Yes

Sponsors