Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency (TRIDENT-1)
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Previous diagnosis of heart failure.
Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
History of an allergic reaction to any xanthine-containing substance.
History of seizure
History of stroke
Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
Serious systemic infection
Major surgical procedures within 30 days
Acute coronary syndrome
Baseline body weight >150 kg
Participation in any other investigational study of drugs or devices within 30 days prior to Screening
Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
Presence of any clinically significant condition that might interfere with optimal safe participation in this study