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NCT00126061
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 Male Subjects With Recent Onset Atrial Fibrillation or Flutter
Phase 3 trial testing Tedisamil sesquifumarate in Atrial Fibrillation. Completed in 1 January 2006.
1 January 2006
Quick facts
| Lead sponsor | Solvay Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 October 2004 |
| Primary completion | 1 January 2006 |
| Estimated completion | 1 January 2006 |
| Sites | 26 locations across United States, Czechia, Poland, Russia, Ukraine |
Drugs / interventions tested
- Tedisamil sesquifumarate — full drug profile →
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Atrial Flutter — all drugs for Atrial Flutter →
Sponsor
Solvay Pharmaceuticals — full company profile →
Who can join
18 and older, male only, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00126061
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
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- NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
- NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
- NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00126061 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Solvay Pharmaceuticals
- Last refreshed: 15 January 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00126061.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing