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NCT00126074

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 or Flutter

Completed Phase 3 Last updated 15 January 2015
What this trial tests

Phase 3 trial testing Tedisamil sesquifumarate in Atrial Fibrillation. Completed in 1 March 2006.

Timeline
1 October 2004
Primary endpoint
1 March 2006
1 March 2006

Quick facts

Lead sponsorSolvay Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Start date1 October 2004
Primary completion1 March 2006
Estimated completion1 March 2006
Sites26 locations across United States, Bulgaria, Germany, Hungary, Italy, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Solvay Pharmaceuticals — full company profile →

Who can join

18 and older, female 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 female patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

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Data sources for this page

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/NCT00126074.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing