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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00709865




Registration number
NCT00709865
Ethics application status
Date submitted
1/07/2008
Date registered
3/07/2008
Date last updated
12/01/2016

Titles & IDs
Public title
Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
Scientific 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
Secondary ID [1] 0 0
160HF301
Universal Trial Number (UTN)
Trial acronym
TRIDENT-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Insufficiency 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tonapofylline
Treatment: Drugs - Placebo

Experimental: 1 - .03 mg/kg

Experimental: 2 - .15 mg/kg

Experimental: 3 - .3 mg/kg

Placebo Comparator: 4 - Placebo


Treatment: Drugs: tonapofylline
IV

Treatment: Drugs: Placebo
IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Timepoint [1] 0 0
0-60 days

Eligibility
Key inclusion criteria
- Previous diagnosis of heart failure.

- Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Liverpool
Recruitment hospital [3] 0 0
- Canberra
Recruitment hospital [4] 0 0
- Dandenong
Recruitment hospital [5] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
ACT 2605 - Canberra
Recruitment postcode(s) [4] 0 0
3175 - Dandenong
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Indiana
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Iowa
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Michigan
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Missouri
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Nebraska
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New Jersey
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West Virginia
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Argentina
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BUE
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Argentina
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CBA
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Argentina
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COR
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Argentina
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CRD
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SFE
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SLS
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TUC
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CE
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Pleven
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Hus
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Lahti
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Oulu
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Tel Aviv
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Italy
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Mantova
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Italy
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Milano
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Italy
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Romania
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Bucuresti
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Tomsk
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Göteborg
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Sweden
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Lidköping

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the current study is to assess the safety and tolerability of intravenous
tonapofylline.
Trial website
https://clinicaltrials.gov/show/NCT00709865
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications