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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:
ClinicalTrials.gov Identifier:
NCT00709865
First Posted: July 3, 2008
Last Update Posted: January 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

Condition Intervention Phase
Renal Insufficiency Congestive Heart Failure Drug: tonapofylline Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ]

Enrollment: 420
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
.03 mg/kg
Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928
Experimental: 2
.15 mg/kg
Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928
Experimental: 3
.3 mg/kg
Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928
Placebo Comparator: 4
Placebo
Drug: Placebo
IV

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709865


  Show 189 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00709865     History of Changes
Other Study ID Numbers: 160HF301
First Submitted: July 1, 2008
First Posted: July 3, 2008
Last Update Posted: January 12, 2016
Last Verified: December 2015

Keywords provided by Biogen:
renal insufficiency
diuretic
congestive heart failure
acute decompensated heart failure

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases