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
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
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014