NCT00709865
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- tonapofylline
- Conditions
- Renal Insufficiency
- Sponsor
- Biogen
- Enrollment
- 420
- Primary Endpoint
- Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
.03 mg/kg
Intervention: tonapofylline
2
.15 mg/kg
Intervention: tonapofylline
3
.3 mg/kg
Intervention: tonapofylline
4
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Time Frame: 0-60 days
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