Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensa… (NCT00709865) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
United States420 participantsStarted 2008-07-31
Plain-language summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Previous diagnosis of heart failure.
* Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Exclusion Criteria:
* History of an allergic reaction to any xanthine-containing substance.
* History of seizure
* History of stroke
* Myocardial infarction
* Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
* Serious systemic infection
* Major surgical procedures within 30 days
* Acute coronary syndrome
* Cardiogenic shock
* 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
What they're measuring
1
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.