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Sponsored by: |
Actelion |
Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00524433 |
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 |
Acute Heart Failure Acute Decompensation of Chronic Heart Failure New Onset of Heart Failure |
Drug: tezosentan Drug: placebo |
Phase III |
MedlinePlus related topics: | Heart Failure |
ChemIDplus related topics: | Tezosentan |
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: | 713 |
Study Start Date: | April 2003 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
1: Experimental
tezosentan
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Drug: tezosentan
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4 mL/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: placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.Patients 18 years of age or older. 2.Male or non-breast-feeding, non-pregnant female (only females who are post menopausal, surgically sterile or practicing a reliable method of contraception).
3.Acute heart failure (ischemic or non-ischemic). 4.Randomization within 24 hours of hospitalization (including emergency room stay) for acute heart failure.
5.Dyspnea at rest as assessed by the patient and breathing rate ³ 24/min (measured during 60 seconds).
6.At least two out of the following four criteria: · elevated BNP or N terminal pro-BNP (more than three times the upper limit of normal for the site) in patients not treated with nesiritide,· clinical evidence of pulmonary congestion/edema (e.g., rales or crackles more than a third above bases),· evidence of pulmonary congestion on chest X-ray, · left ventricular systolic dysfunction (EF < 40% or wall motion index £ 1.2 within 12 months prior to randomization).
7.Patients in need of i.v. therapy for acute heart failure and who have received at least one dose of i.v. diuretic within 24 hours prior to study drug initiation (last bolus dose must have been more than 2 hours prior to study drug initiation).
8.Written informed consent.
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:
Show 42 Study Locations |
Actelion |
Actelion trials website 
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Study ID Numbers: | AC-051-307 |
First Received: | August 31, 2007 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00524433 |
Health Authority: | United States: Food and Drug Administration |
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