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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00525707 |
The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.
Condition | Intervention | Phase |
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Acute Heart Failure Acute Decompensation of Chronic Heart Failure New Onset of Heart Failure |
Drug: tezosentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure. |
Enrollment: | 735 |
Study Start Date: | April 2003 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
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1: Experimental
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
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Drug: tezosentan
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
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2: Placebo Comparator |
Drug: tezosentan
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Criteria only for patients hemodynamically monitored:
Baseline cardiac index > 2.5 l/min/m2 and/or PCWP < 20 mmHg within 6 hours prior to study drug initiation.
Criteria for all patients:
Study ID Numbers: | AC-051-306 |
Study First Received: | August 31, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00525707 |
Health Authority: | United States: Food and Drug Administration |
acute heart failure Actelion tezosentan acute decompensation of chronic heart failure New onset of heart failure |
Tezosentan Heart Failure Heart Diseases |
Vasodilator Agents Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |