Atrial FibrillationPhase 3NCT00126022
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
A Phase 3 study testing Tedisamil sesquifumarate in people with Atrial Fibrillation and Atrial Flutter, run by Solvay Pharmaceuticals at 81 sites in 13 countries.
Trial summary
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Tedisamil sesquifumarate
- How many people
- Not given
- Where
- 81 sitesin 13 countries
- Study dates
- Dec 2004to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign informed consent before screening examinations are performed and before the study drug is administered
- Females > 18 years of age
- Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization
- Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmHg and diastolic blood pressure < 105 mmHg)
Who cannot join
- Pregnancy and lactation
- Acute myocardial infarction and cerebrovascular accidents
- Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
- Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
- Concurrent antiarrhythmic treatments
Trial locations and contacts
81 sites in 13 countries.
81 sites in 13 countries
Poland13 sites
Site 26
Bydgoszcz
Site 32
Bydgoszcz
Site 30
Lodz
Site 29
Lublin
Site 36
Lublin
Site 31
Medyczna
Site 33
Szczecin
Site 24
Warsaw
Site 25
Warsaw
Site 27
Warsaw
Site 28
Warsaw
Site 34
Wroclaw
Site 35
Wroclaw
Ukraine13 sites
Site 68
Dnipro
Site 69
Dnipro
Site 71
Donetsk
Site 72
Donetsk
Site 75
Kharkiv
Site 70
Kiev
Site 73
Kiev
Site 76
Kiev
Site 77
Kiev
Site 74
Lviv
Site 80
Odesa
Site 79
Zaporizhya
Site 78
Zaporizhzhya
Russia11 sites
Site 41
Moscow
Site 42
Moscow
Site 43
Moscow
Site 44
Moscow
Site 45
Moscow
Site 46
Moscow
Site 47
Moscow
Site 48
Moscow
Site 49
Moscow
Site 51
Moscow
Site 50
Saint Petersburg
Czechia9 sites
Site 8
Brno
Site 11
Jindřichův Hradec
Site 9
Ostrava-Poruba
Site 10
Pilsen
Site 14
Prague
Site 6
Prague
Site 7
Prague
Site 12
Slaný
Site 13
Ústí nad Orlicí
Serbia and Montenegro7 sites
Site 52
Belgrade
Site 53
Belgrade
Site 54
Belgrade
Site 57
Belgrade
Site 58
Belgrade
Site 56
Niska Banja
Site 55
Sremska Kamenica
Slovakia7 sites
Site 60
Banská Bystrica
Site 64
Bratislava
Site 61
Košice
Site 62
Lučenec
Site 59
Nitra
Site 65
Nové Zámky
Site 63
Prešov
Israel6 sites
Site 18
Haifa
Site 19
Jerusalem
Site 22
Jerusalem
Site 23
Jerusalem
Site 20
Tel Aviv
Site 21
Tel Aviv
Argentina4 sites
Site 2
Buenos Aires
Site 3
Buenos Aires
Site 5
Munro
Site 4
San Miguel de Tucumán
Romania4 sites
Site 38
Brasov
Site 39
Bucharest
Site 40
Bucharest
Site 37
Tg. Mures
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Tedisamil sesquifumarate
- Keywords
- Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedisamil sesquifumarateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startDec 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126022
- Sponsor's protocol ID
- S219.3.116
- Other IDs
- 2004-000460-27, 2004
- Status last verified
- Mar 2006
- First submitted
- 1 Aug 2005
- Last updated
- 16 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00126022
- Acronym / sponsor ID
- S219.3.116
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to sign informed consent before screening examinations are performed and before the study drug is administered
- Females > 18 years of age
- Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization
- Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmHg and diastolic blood pressure < 105 mmHg)
Key exclusion criteria (5 listed)
- Pregnancy and lactation
- Acute myocardial infarction and cerebrovascular accidents
- Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
- Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
- Concurrent antiarrhythmic treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tedisamil sesquifumarate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
81 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tedisamil sesquifumarate in people with Atrial Fibrillation and Atrial Flutter, run by Solvay Pharmaceuticals at 81 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in Poland, Ukraine, Russia, Czechia, Serbia and Montenegro and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.