Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00709865
First received: July 1, 2008
Last updated: December 8, 2009
Last verified: December 2009
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Idec:

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 ] [ Designated as safety issue: Yes ]

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 Name: Adentri, BG9928, tonapofylline
Experimental: 2
.15 mg/kg
Drug: tonapofylline
IV
Other Name: Adentri, BG9928, tonapofylline
Experimental: 3
.3 mg/kg
Drug: tonapofylline
IV
Other Name: Adentri, BG9928, tonapofylline
Placebo Comparator: 4
Placebo
Drug: Placebo
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709865

  Show 189 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00709865     History of Changes
Other Study ID Numbers: 160HF301
Study First Received: July 1, 2008
Last Updated: December 8, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Bulgaria: Ministry of Health
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: Ministry of Health
Romania: National Medicines Agency
Sweden: Medical Products Agency
Russia: Pharmacological Committee, Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014