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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 1, 2008
Last Updated Date	December 8, 2009
Start Date ^ICMJE	July 2008
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: July 2, 2008)	To assess the clinical effect of BG9928, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Change History	Complete list of historical versions of study NCT00709865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
Official Title ^ICMJE	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
Brief Summary	The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Congestive Heart Failure Renal Insufficiency
Intervention ^ICMJE	Drug: tonapofylline IV Other Name: Adentri, BG9928, tonapofylline Drug: Placebo IV
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	420
Completion Date	December 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Brazil, Bulgaria, Canada, Czech Republic, Finland, France, Germany, India, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Sweden

Administrative Information
NCT Number ^ICMJE	NCT00709865
Other Study ID Numbers ^ICMJE	160HF301
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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