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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00616629 |
The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures
Condition | Intervention | Phase |
---|---|---|
Atrial Flutter |
Drug: AZD1305 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Pharmacodynamics Study |
Official Title: | A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure |
Estimated Enrollment: | 48 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Research Site | |
Aalborg, Denmark | |
Research Site | |
Arhus, Denmark | |
Research Site | |
Hellerup, Denmark | |
Research Site | |
København, Denmark | |
Finland | |
Research Site | |
Helsinki, Finland | |
Research Site | |
Kuopio, Finland | |
Research Site | |
Oulu, Finland | |
Norway | |
Research Site | |
Bergen, Norway | |
Research Site | |
Oslo, Norway | |
Sweden | |
Research Site | |
Gŏteborg, Sweden | |
Research Site | |
Umea, Sweden | |
Research Site | |
Ŏrebro, Sweden | |
Research Site | |
Linkŏping, Sweden |
Principal Investigator: | Lauri Toivonen, MD | Helsinki University Hospital |
Responsible Party: | AstraZeneca ( AstraZeneca AZD1305 Medical Science Director ) |
Study ID Numbers: | D3190C00005, 2007-0003455-36 (EudraCT No) |
Study First Received: | February 5, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00616629 |
Health Authority: | Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines |
Heart Diseases Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |