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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00130871
Other study ID # 3001079
Secondary ID
Status Completed
Phase Phase 2
First received August 15, 2005
Last updated February 19, 2007
Start date January 2004
Est. completion date January 2006

Study information

Verified date February 2007
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.


Description:

Levosimendan or placebo infusion is started at the time of induction of anesthesia.


Other known NCT identifiers
  • NCT00195832

Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Three vessel coronary artery disease.

- Indication for on-pump coronary artery bypass surgery.

- Ejection fraction below 50%

Exclusion Criteria:

- Indication for any cardiac valve surgery

- Previous coronary artery bypass surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
levosimendan


Locations

Country Name City State
Finland Helsinki University Central Hospital Helsinki
Finland Turku University Central Hospital Turku

Sponsors (1)

Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of successful primary weanings
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