Status:
COMPLETED
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
Lead Sponsor:
Biogen
Conditions:
Renal Insufficiency
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Eligibility Criteria
Inclusion
- Previous diagnosis of heart failure.
- Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2009
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00709865
Start Date
July 31 2008
End Date
December 31 2009
Last Update
September 11 2023
Active Locations (189)
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1
Huntsville, Alabama, United States, 35801
2
Mobile, Alabama, United States, 36608
3
Fort Smith, Arkansas, United States, 72917
4
Beverly Hills, California, United States, 90210