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Sponsored by: |
CV Therapeutics |
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Information provided by: | CV Therapeutics |
ClinicalTrials.gov Identifier: | NCT00713401 |
Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Drug: Tecadenoson |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | An Open-Label, Sequential-Group, Dose-Escalation Study To Evaluate The Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Tecadenoson Alone and in Combination With a Beta-Blocker in Adults With Rapid Atrial Fibrillation (CVT 4129) |
Enrollment: | 21 |
Study Start Date: | February 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Tecadenoson
|
Drug: Tecadenoson
Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol low dose infusion.
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B: Experimental
Tecadenoson
|
Drug: Tecadenoson
Period 1: 150 mcg, IV bolus. Period 2: 150 mcg, IV bolus + esmolol low dose infusion.
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C: Experimental
Tecadenoson
|
Drug: Tecadenoson
Period 1: 300 mcg, IV bolus. Period 2: 300 mcg, IV bolus + esmolol low dose infusion.
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D: Experimental
Tecadenoson
|
Drug: Tecadenoson
Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol high dose infusion.
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E: Experimental
Tecadenoson
|
Drug: Tecadenoson
Period 1: 150 or 300 mcg, IV bolus. Period 2: 150 or 300 mcg, IV bolus + esmolol high dose infusion.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CV Therapeutics ( Carol D. Karp, Senior Vice President, Regulatory Affairs, Quality and Drug Safety ) |
Study ID Numbers: | CVT 4129 |
Study First Received: | July 9, 2008 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00713401 |
Health Authority: | United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation |
Heart Diseases Esmolol Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |