Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency (TRIDENT-1)

Biogen

Status and phase: Completed; Phase 3

Conditions: Renal Insufficiency; Congestive Heart Failure

Treatments: Drug: Placebo; Drug: tonapofylline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709865

160HF301

Details and patient eligibility

About

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

420 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

.03 mg/kg

Treatment:

Drug: tonapofylline

2

Experimental group

Description:

.15 mg/kg

Treatment:

Drug: tonapofylline

3

Experimental group

Description:

.3 mg/kg

Treatment:

Drug: tonapofylline

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo