Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
TRIDENT-1
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
1 other identifier
interventional
420
18 countries
189
Brief Summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2008
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedStudy Start
First participant enrolled
July 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2009
CompletedSeptember 11, 2023
September 1, 2023
1.2 years
July 1, 2008
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
0-60 days
Study Arms (4)
1
EXPERIMENTAL.03 mg/kg
2
EXPERIMENTAL.15 mg/kg
3
EXPERIMENTAL.3 mg/kg
4
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Previous diagnosis of heart failure.
- Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (189)
Unknown Facility
Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Fort Smith, Arkansas, 72917, United States
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Beverly Hills, California, 90210, United States
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Chula Vista, California, 91911, United States
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Mission Viejo, California, 92691, United States
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Monterey Park, California, 91754, United States
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Oceanside, California, 92056, United States
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Redondo Beach, California, 90277, United States
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San Diego, California, 92103, United States
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Sylmar, California, 91342, United States
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Torrance, California, 90502, United States
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Yuba City, California, 95991, United States
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Hartford, Connecticut, 06102, United States
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Jacksonville, Florida, 32216, United States
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Sarasota, Florida, 34239, United States
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Tampa, Florida, 33613, United States
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Lombard, Illinois, 60148, United States
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Indianapolis, Indiana, 46202, United States
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Muncie, Indiana, 47303, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 64132, United States
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Wichita, Kansas, 67220, United States
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Baltimore, Maryland, 21201, United States
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Ayer, Massachusetts, 01432, United States
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Boston, Massachusetts, 02114, United States
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Hyannis, Massachusetts, 02601, United States
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Springfield, Massachusetts, 01107, United States
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West Springfield, Massachusetts, 01089, United States
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Traverse City, Michigan, 49684, United States
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Minneapolis, Minnesota, 55404, United States
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Kansas City, Missouri, 64132, United States
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Lee's Summit, Missouri, 64063, United States
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St Louis, Missouri, 63128, United States
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Omaha, Nebraska, 68131, United States
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Ridgewood, New Jersey, 07450, United States
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Johnson City, New York, 13790, United States
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Mineola, New York, 11501, United States
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New York, New York, 10021, United States
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Stony Brook, New York, 11794, United States
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The Bronx, New York, 10461, United States
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Concord, North Carolina, 28025, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Franklin, Ohio, 45005, United States
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Oklahoma City, Oklahoma, 73109, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74104, United States
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Portland, Oregon, 97213, United States
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Camp Hill, Pennsylvania, 17011, United States
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Danville, Pennsylvania, 17822, United States
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Doylestown, Pennsylvania, 18901, United States
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Lancaster, Pennsylvania, 17603, United States
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Philadelphia, Pennsylvania, 19140, United States
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Providence, Rhode Island, 02908, United States
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Orangeburg, South Carolina, 29118, United States
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Nashville, Tennessee, 37208, United States
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Oak Ridge, Tennessee, 37830, United States
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Tullahoma, Tennessee, 37388, United States
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Dallas, Texas, 75216, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78215, United States
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Whitney, Texas, 76692, United States
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Danville, Virginia, 24541, United States
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Olympia, Washington, 98506, United States
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Tacoma, Washington, 98405, United States
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Charleston, West Virginia, 25304, United States
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Buenos Aires, BUE, B1605DSX, Argentina
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Buenos Aires, BUE, B1722COV, Argentina
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Capital Federal, CBA, C1280AEB, Argentina
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Corrientes, COR, W3400AMZ, Argentina
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Córdoba, CRD, X5004CDT, Argentina
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Villa Cabrera, CRD, X5009BSN, Argentina
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Santa Fe, SFE, 3000, Argentina
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Santa Fe, SFE, S3000FUJ, Argentina
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San Luis, SLS, D5702JRS, Argentina
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San Miguel de Tucumán, TUC, 4000, Argentina
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Capital Federal, C1437JCP, Argentina
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Darlinghurst, New South Wales, 2010, Australia
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Liverpool, New South Wales, 2170, Australia
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Canberra, ACT 2605, Australia
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Dandenong, 3175, Australia
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Melbourne, 3004, Australia
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Fortaleza, Ceará, 60864-190, Brazil
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Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
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Aracaju, Sergipe, 49015-400, Brazil
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Santo André, São Paulo, 09190-610, Brazil
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São José do Rio Preto, São Paulo, 15015-210, Brazil
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Campo Grande, 79080-190, Brazil
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Curitiba, 80010-030, Brazil
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Porto Alegre, 90620-001, Brazil
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Porto Alegre, CEP 90350-200, Brazil
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Recife, 50100-010, Brazil
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Pazardzhik, 4400, Bulgaria
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Pleven, 5800, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1606, Bulgaria
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Vancouver, British Columbia, V5Z 1M9, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Kolín, 280 20, Czechia
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Uherské Hradiště, 686 68, Czechia
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Hus, 29, Finland
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Lahti, 15850, Finland
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Oulu, 90220, Finland
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Seinäjoki, 60220, Finland
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Turku, 20520, Finland
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Albi, 81000, France
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Antony, 92 92166, France
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Caen, 14033, France
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Cholet, 49 49325, France
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Paris, 75 75651, France
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Poitiers, 86 86021, France
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Pontoise, 95300, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Tourcoinq, 59208, France
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Frankfurt am Main, Hesse, 60488, Germany
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Bad Nauheim, HE 61231, Germany
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Berlin, BE 12559, Germany
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Berlin, BE 13353, Germany
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Bochum, NW 44791, Germany
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Essen, NW 45138, Germany
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Frankfurt, HE 60590, Germany
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Göttingen, NI 37075, Germany
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Leipzig, 4289, Germany
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Regensburg, BY 93042, Germany
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Wuppertal, NW 42117, Germany
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Bangalore, Karna, 562158, India
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Pune, Mahara, 411004, India
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New Delhi, National Capital Territory of Delhi, 110060, India
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Bangalore, 560034, India
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Bikaner, 334003, India
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Chennai, 600037, India
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Delhi, 110055, India
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Indore, 452018, India
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Thrissur, 680002, India
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Ashkelon, 78306, Israel
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Beer Yaakov, 70300, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Jerusalem, 91240, Israel
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Kfar Saba, 44281, Israel
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Nahariya, 22100, Israel
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Nazareth, 16000, Israel
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Petah Tikva, 49100, Israel
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Safed, 13100, Israel
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Tel Aviv, 64239, Israel
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Mantova, 46100, Italy
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Milan, 20162, Italy
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Pavia, PV 27100, Italy
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Maastricht, 6229 HX, Netherlands
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The Hague, 2512 VA, Netherlands
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Zwolle, 8011 JW, Netherlands
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Kościerzyna, 83-400, Poland
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Olsztyn, 10-045, Poland
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Słupsk, 76-200, Poland
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Tarnów, 33-100, Poland
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Warsaw, 00-909, Poland
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Warsaw, 04-628, Poland
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Wroclaw, 50-981, Poland
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Wroclaw, 51-124, Poland
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Bacau, 600114, Romania
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Bucharest, 20125, Romania
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Bucharest, 21659, Romania
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Bucharest, 22328, Romania
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Barnaul, 656099, Russia
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Kemerovo, 650002, Russia
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Krasnoyarsk, 660062, Russia
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Moscow, 113093, Russia
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Moscow, 123182, Russia
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Moscow, 125101, Russia
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Moscow, 127473, Russia
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Moscow, 127644, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630075, Russia
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Novosibirsk, 630090, Russia
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Saint Petersburg, 192242, Russia
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Saint Petersburg, 193318, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 199106, Russia
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Saratov, 410028, Russia
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Tomsk, 634012, Russia
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Gothenburg, 413 45, Sweden
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Lidköping, 53185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
July 31, 2008
Primary Completion
October 30, 2009
Study Completion
December 31, 2009
Last Updated
September 11, 2023
Record last verified: 2023-09