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

Congestive Heart Failure Clinical Trial

— TRIDENT-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709865
• Other study ID #: 160HF301
• Status: Completed
• Phase: Phase 3
• Start date: July 31, 2008
• Est. completion date: December 31, 2009

Study information

• Verified date: September 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 31, 2009
• Est. primary completion date: October 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Renal Insufficiency

Intervention

Drug:
• tonapofylline
IV
• Placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Czechia,  Finland,  France,  Germany,  India,  Israel,  Italy,  Netherlands,  Poland,  Romania,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.		0-60 days