A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure
This study has been completed.
Sponsor:
Bio-Medisinsk Innovasjon
Collaborator:
Smerud Medical Research International AS
Information provided by:
Bio-Medisinsk Innovasjon
ClinicalTrials.gov Identifier:
NCT00421746
First received: January 11, 2007
Last updated: August 2, 2007
Last verified: August 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Drug: Piboserod |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Proof of Biological Efficacy Study Assessing the Potential of Piboserod, a Specific 5-HT4 Antagonist, for the Treatment of Symptomatic Congestive Heart Failure on Top of Usual Evidence Based Pharmacological Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Serotonin
U.S. FDA Resources
Further study details as provided by Bio-Medisinsk Innovasjon:
Primary Outcome Measures:
- Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging [ Time Frame: 6 months ]
Secondary Outcome Measures:
- Change in LV systolic and diastolic volume (and/or diameter) by CMR [ Time Frame: 6 months ]
- Change in NYHA functional class [ Time Frame: 6 months ]
- Change in various biomarkers for heart failure [ Time Frame: 6 months ]
- Change in QoL-scores [ Time Frame: 6 months ]
- Change in 6-minute walk distance [ Time Frame: 6 months ]
| Enrollment: | 137 |
| Study Start Date: | January 2006 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421746
Locations
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| Amager Hospital | |
| Copenhagen, Denmark, 2300 | |
| Bispebjerg Hospital | |
| Copenhagen, Denmark, 2400 | |
| Frederiksberg Hospital | |
| Frederiksberg, Denmark, 2000 | |
| Amtsygehuset i Herlev | |
| Herlev, Denmark, 2730 | |
| Hvidovre Hospital | |
| Hvidovre, Denmark, 2650 | |
| Odense Universitets Hospital | |
| Odense, Denmark, 5000 | |
| Svendborg Sygehus | |
| Svendborg, Denmark, 5700 | |
| Norway | |
| Østlandske Hjertesenter | |
| Moss, Norway, 1530 | |
| Fana Hjertesenter | |
| Nesttun, Norway, 5221 | |
| Rikshospitalet | |
| Oslo, Norway, 0027 | |
| Ullevål Universitetssykehus | |
| Oslo, Norway, 0407 | |
| Stavanger Universitetssjukehus | |
| Stavanger, Norway | |
| St. Olavs Hospital | |
| Trondheim, Norway, 7006 | |
| United Kingdom | |
| Castel Hill Hospital | |
| Cottingham, East Yorkshire, United Kingdom, HU16 5JQ | |
| Bridlington and District General Hospital | |
| Bridlington, United Kingdom, YO16 4QP | |
| Western Infirmary | |
| Glasgow, United Kingdom, G11 6NT | |
Sponsors and Collaborators
Bio-Medisinsk Innovasjon
Smerud Medical Research International AS
Investigators
| Study Chair: | Christian Torp-Pedersen, Dr. Med | Bispebjerg Hospital, Copenhagen, Denmark |
More Information
Additional Information:
No publications provided by Bio-Medisinsk Innovasjon
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00421746 History of Changes |
| Other Study ID Numbers: | BMI 001 / SMR-1389 |
| Study First Received: | January 11, 2007 |
| Last Updated: | August 2, 2007 |
| Health Authority: | Norway: Norwegian Medicines Agency Denmark: Danish Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Serotonin 5-HT4 Receptor Antagonists Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013