Status:
COMPLETED
A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
Lead Sponsor:
Bio-Medisinsk Innovasjon
Collaborating Sponsors:
Smerud Medical Research International AS
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.
Detailed Description
Despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. There is an obvious need for new drugs, especially drugs which may have a different mode of...
Eligibility Criteria
Inclusion
- Clinical diagnosis of CHF (NYHA class II-IV)
- Locally determined LVEF \< 0.35 (by CMR, echocardiography, LV angiography, or radionuclide cardioangiography)
- Stable sinus rhythm
- Stable evidence based pharmacological treatment for CHF.
Exclusion
- Unstable patients hospitalised within last 2 weeks
- Baseline prolongation of QTc interval
- Atrial fibrillation at randomisation
- MI or re-vascularisation last 3 months
- Stroke last 3 months.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00421746
Start Date
January 1 2006
End Date
July 1 2007
Last Update
August 3 2007
Active Locations (17)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Amager Hospital
Copenhagen, Denmark, 2300
3
Bispebjerg Hospital
Copenhagen, Denmark, 2400
4
Frederiksberg Hospital
Frederiksberg, Denmark, 2000