Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency (TRIDENT-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00709865
First received: July 1, 2008
Last updated: December 10, 2015
Last verified: December 2015

July 1, 2008
December 10, 2015
July 2008
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
To assess the clinical effect of BG9928, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Complete list of historical versions of study NCT00709865 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
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
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Renal Insufficiency
  • Congestive Heart Failure
  • Drug: tonapofylline
    IV
    Other Names:
    • Adentri
    • BG9928
  • Drug: Placebo
    IV
  • Experimental: 1
    .03 mg/kg
    Intervention: Drug: tonapofylline
  • Experimental: 2
    .15 mg/kg
    Intervention: Drug: tonapofylline
  • Experimental: 3
    .3 mg/kg
    Intervention: Drug: tonapofylline
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
December 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   India,   Israel,   Italy,   Netherlands,   Poland,   Romania,   Russian Federation,   Sweden
 
NCT00709865
160HF301
Yes
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP