Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00709865
Ethics application status
Date submitted
1/07/2008
Date registered
3/07/2008
Date last updated
11/09/2023

Titles & IDs
Public title
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
Sex
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 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
31/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2009
Sample size
Target
Accrual to date
Final
420
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
West Virginia
Country [30] 0 0
Argentina
State/province [30] 0 0
BUE
Country [31] 0 0
Argentina
State/province [31] 0 0
CBA
Country [32] 0 0
Argentina
State/province [32] 0 0
COR
Country [33] 0 0
Argentina
State/province [33] 0 0
CRD
Country [34] 0 0
Argentina
State/province [34] 0 0
SFE
Country [35] 0 0
Argentina
State/province [35] 0 0
SLS
Country [36] 0 0
Argentina
State/province [36] 0 0
TUC
Country [37] 0 0
Argentina
State/province [37] 0 0
Capital Federal
Country [38] 0 0
Brazil
State/province [38] 0 0
CE
Country [39] 0 0
Brazil
State/province [39] 0 0
RS
Country [40] 0 0
Brazil
State/province [40] 0 0
SE
Country [41] 0 0
Brazil
State/province [41] 0 0
SP
Country [42] 0 0
Brazil
State/province [42] 0 0
Campo Grande
Country [43] 0 0
Brazil
State/province [43] 0 0
Curitiba
Country [44] 0 0
Brazil
State/province [44] 0 0
Porto Alegre
Country [45] 0 0
Brazil
State/province [45] 0 0
Recife
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Pazardjik
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Pleven
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Sofia
Country [49] 0 0
Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
New Brunswick
Country [51] 0 0
Czechia
State/province [51] 0 0
Kolin
Country [52] 0 0
Czechia
State/province [52] 0 0
Uherske Hradiste
Country [53] 0 0
Finland
State/province [53] 0 0
Hus
Country [54] 0 0
Finland
State/province [54] 0 0
Lahti
Country [55] 0 0
Finland
State/province [55] 0 0
Oulu
Country [56] 0 0
Finland
State/province [56] 0 0
Seinäjoki
Country [57] 0 0
Finland
State/province [57] 0 0
Turku
Country [58] 0 0
France
State/province [58] 0 0
Albi
Country [59] 0 0
France
State/province [59] 0 0
Antony cedex
Country [60] 0 0
France
State/province [60] 0 0
Caen
Country [61] 0 0
France
State/province [61] 0 0
Cholet Cedex
Country [62] 0 0
France
State/province [62] 0 0
Paris cedex 13
Country [63] 0 0
France
State/province [63] 0 0
Poitiers
Country [64] 0 0
France
State/province [64] 0 0
Pontoise
Country [65] 0 0
France
State/province [65] 0 0
Strasbourg Cedex
Country [66] 0 0
France
State/province [66] 0 0
Toulouse Cedex 9
Country [67] 0 0
France
State/province [67] 0 0
Tourcoinq
Country [68] 0 0
Germany
State/province [68] 0 0
HE
Country [69] 0 0
Germany
State/province [69] 0 0
Bad Nauheim
Country [70] 0 0
Germany
State/province [70] 0 0
Berlin
Country [71] 0 0
Germany
State/province [71] 0 0
Bochum
Country [72] 0 0
Germany
State/province [72] 0 0
Essen
Country [73] 0 0
Germany
State/province [73] 0 0
Frankfurt
Country [74] 0 0
Germany
State/province [74] 0 0
Göttingen
Country [75] 0 0
Germany
State/province [75] 0 0
Leipzig
Country [76] 0 0
Germany
State/province [76] 0 0
Regensburg
Country [77] 0 0
Germany
State/province [77] 0 0
Wuppertal
Country [78] 0 0
India
State/province [78] 0 0
Delhi
Country [79] 0 0
India
State/province [79] 0 0
Karna
Country [80] 0 0
India
State/province [80] 0 0
Mahara
Country [81] 0 0
India
State/province [81] 0 0
Bangalore
Country [82] 0 0
India
State/province [82] 0 0
Bikaner
Country [83] 0 0
India
State/province [83] 0 0
Chennai
Country [84] 0 0
India
State/province [84] 0 0
Indore
Country [85] 0 0
India
State/province [85] 0 0
Thrissur
Country [86] 0 0
Israel
State/province [86] 0 0
Ashkelon
Country [87] 0 0
Israel
State/province [87] 0 0
Beer Yaakov
Country [88] 0 0
Israel
State/province [88] 0 0
Haifa
Country [89] 0 0
Israel
State/province [89] 0 0
Holon
Country [90] 0 0
Israel
State/province [90] 0 0
Jerusalem
Country [91] 0 0
Israel
State/province [91] 0 0
Kfar Saba
Country [92] 0 0
Israel
State/province [92] 0 0
Nahariya
Country [93] 0 0
Israel
State/province [93] 0 0
Nazareth
Country [94] 0 0
Israel
State/province [94] 0 0
Petach Tikva
Country [95] 0 0
Israel
State/province [95] 0 0
Safed
Country [96] 0 0
Israel
State/province [96] 0 0
Tel Aviv
Country [97] 0 0
Italy
State/province [97] 0 0
Mantova
Country [98] 0 0
Italy
State/province [98] 0 0
Milano
Country [99] 0 0
Italy
State/province [99] 0 0
Pavia
Country [100] 0 0
Netherlands
State/province [100] 0 0
Den Haag
Country [101] 0 0
Netherlands
State/province [101] 0 0
Maastricht
Country [102] 0 0
Netherlands
State/province [102] 0 0
Zwolle
Country [103] 0 0
Poland
State/province [103] 0 0
Koscierzyna
Country [104] 0 0
Poland
State/province [104] 0 0
Olsztyn
Country [105] 0 0
Poland
State/province [105] 0 0
Slupsk
Country [106] 0 0
Poland
State/province [106] 0 0
Tarnow
Country [107] 0 0
Poland
State/province [107] 0 0
Warszawa
Country [108] 0 0
Poland
State/province [108] 0 0
Wroclaw
Country [109] 0 0
Romania
State/province [109] 0 0
Bacau
Country [110] 0 0
Romania
State/province [110] 0 0
Bucuresti
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Barnaul
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Kemerovo
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Krasnoyarsk
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moscow
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Novosibirsk
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Saratov
Country [117] 0 0
Russian Federation
State/province [117] 0 0
St-Petersburg
Country [118] 0 0
Russian Federation
State/province [118] 0 0
St. Petersburg
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Tomsk
Country [120] 0 0
Sweden
State/province [120] 0 0
Göteborg
Country [121] 0 0
Sweden
State/province [121] 0 0
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00709865