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A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure

NCT ID: NCT00421746

Last Updated: 2007-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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 action than the existing ones on the market.

The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Piboserod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smerud Medical Research International AS

OTHER

Sponsor Role collaborator

Bio-Medisinsk Innovasjon

INDUSTRY

Sponsor Role lead

Principal Investigators

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Christian Torp-Pedersen, Dr. Med

Role: STUDY_CHAIR

Bispebjerg Hospital, Copenhagen, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Amager Hospital

Copenhagen, , Denmark

Site Status

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Frederiksberg Hospital

Frederiksberg, , Denmark

Site Status

Amtsygehuset i Herlev

Herlev, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Odense Universitets Hospital

Odense, , Denmark

Site Status

Svendborg Sygehus

Svendborg, , Denmark

Site Status

Østlandske Hjertesenter

Moss, , Norway

Site Status

Fana Hjertesenter

Nesttun, , Norway

Site Status

Rikshospitalet

Oslo, , Norway

Site Status

Ullevål Universitetssykehus

Oslo, , Norway

Site Status

Stavanger Universitetssjukehus

Stavanger, , Norway

Site Status

St. Olavs Hospital

Trondheim, , Norway

Site Status

Castel Hill Hospital

Cottingham, East Yorkshire, United Kingdom

Site Status

Bridlington and District General Hospital

Bridlington, , United Kingdom

Site Status

Western Infirmary

Glasgow, , United Kingdom

Site Status

Countries

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Denmark Norway United Kingdom

References

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Kjekshus JK, Torp-Pedersen C, Gullestad L, Kober L, Edvardsen T, Olsen IC, Sjaastad I, Qvigstad E, Skomedal T, Osnes JB, Levy FO. Effect of piboserod, a 5-HT4 serotonin receptor antagonist, on left ventricular function in patients with symptomatic heart failure. Eur J Heart Fail. 2009 Aug;11(8):771-8. doi: 10.1093/eurjhf/hfp087. Epub 2009 Jun 30.

Reference Type DERIVED
PMID: 19567409 (View on PubMed)

Related Links

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http://www.bmioslo.no

Sponsor's web site

Other Identifiers

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BMI 001 / SMR-1389

Identifier Type: -

Identifier Source: org_study_id