Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
Phase 3
Completed
- Conditions
- Renal InsufficiencyCongestive Heart Failure
- Interventions
- Drug: Placebo
- Registration Number
- NCT00709865
- Lead Sponsor
- Biogen
- Brief Summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tonapofylline .03 mg/kg 2 tonapofylline .15 mg/kg 3 tonapofylline .3 mg/kg 4 Placebo Placebo
- Primary Outcome Measures
Name Time Method Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency. 0-60 days
- Secondary Outcome Measures
Name Time Method