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:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00709865
First received: July 1, 2008
Last updated: December 8, 2009
Last verified: December 2009
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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
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| United States, Alabama | |
| Huntsville, Alabama, United States, 35801 | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arkansas | |
| Ft. Smith, Arkansas, United States, 72917 | |
| United States, California | |
| Beverly Hills, California, United States, 90210 | |
| Chula Vista, California, United States, 91911 | |
| Mission Viego, California, United States, 92691 | |
| Monterey Park, California, United States, 91754 | |
| Oceanside, California, United States, 92056 | |
| Redondo Beach, California, United States, 90277 | |
| San Diego, California, United States, 92103 | |
| Sylmar, California, United States, 91342 | |
| Torrance, California, United States, 90502 | |
| Yuba City, California, United States, 95991 | |
| United States, Connecticut | |
| Hartford, Connecticut, United States, 6102 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32216 | |
| Sarasota, Florida, United States, 34239 | |
| Tampa, Florida, United States, 33613 | |
| United States, Illinois | |
| Lombard, Illinois, United States, 60148 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Muncie, Indiana, United States, 47303 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Kansas City, Kansas, United States, 64132 | |
| Wichita, Kansas, United States, 67220 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Ayer, Massachusetts, United States, 01432 | |
| Boston, Massachusetts, United States, 02114 | |
| Hyannis, Massachusetts, United States, 02601 | |
| Springfield, Massachusetts, United States, 01107 | |
| West Springfield, Massachusetts, United States, 01089 | |
| United States, Michigan | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Missouri | |
| Kansas City, Missouri, United States, 64132 | |
| Lee's Summit, Missouri, United States, 64063 | |
| St. Louis, Missouri, United States, 63128 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| Bronx, New York, United States, 10461 | |
| Johnson City, New York, United States, 13790 | |
| Mineola, New York, United States, 11501 | |
| New York City, New York, United States, 10021 | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Concord, North Carolina, United States, 28025 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| Cleveland, Ohio, United States, 44195 | |
| Columbus, Ohio, United States, 43210 | |
| Franklin, Ohio, United States, 45005 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Oklahoma City, Oklahoma, United States, 73109 | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Camphill, Pennsylvania, United States, 17011 | |
| Danville, Pennsylvania, United States, 17822 | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Rhode Island | |
| Providence, Rhode Island, United States, 02908 | |
| United States, South Carolina | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37208 | |
| Oak Ridge, Tennessee, United States, 37830 | |
| Tullahoma, Tennessee, United States, 37388 | |
| United States, Texas | |
| Dallas, Texas, United States, 75216 | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78215 | |
| Whitney, Texas, United States, 76692 | |
| United States, Virginia | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Olympia, Washington, United States, 98506 | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| Charleston, West Virginia, United States, 25304 | |
| Argentina | |
| Buenos Aires, BUE, Argentina, B1722COV | |
| Buenos Aires, BUE, Argentina, B1605DSX | |
| Capital Federal, CBA, Argentina, C1280AEB | |
| Corrientes, COR, Argentina, W3400AMZ | |
| Cordoba, CRD, Argentina, X5004CDT | |
| Villa Cabrera, CRD, Argentina, X5009BSN | |
| Santa Fe, SFE, Argentina, S3000FUJ | |
| Santa Fe, SFE, Argentina, 3000 | |
| San Luis, SLS, Argentina, D5702JRS | |
| Tucuman, TUC, Argentina, 4000 | |
| Capital Federal, Argentina, C1437JCP | |
| Australia, New South Wales | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Liverpool, New South Wales, Australia, 2170 | |
| Australia | |
| Canberra, Australia, ACT 2605 | |
| Dandenong, Australia, 3175 | |
| Melbourne, Australia, 3004 | |
| Brazil | |
| Fortaleza, CE, Brazil, 60864-190 | |
| Porto Alegre, RS, Brazil, 90110-270 | |
| Aracaju, SE, Brazil, 49015-400 | |
| Santo Andre, SP, Brazil, 09190-610 | |
| Sao Jose Do Rio Preto, SP, Brazil, 15015-210 | |
| Campo Grande, Brazil, 79080-190 | |
| Curitiba, Brazil, 80010-030 | |
| Porto Alegre, Brazil, 90620-001 | |
| Porto Alegre, Brazil, CEP 90350-200 | |
| Recife, Brazil, 50100-010 | |
| Bulgaria | |
| Pazardjik, Bulgaria, 4400 | |
| Pleven, Bulgaria, 5800 | |
| Sofia, Bulgaria, 1202 | |
| Sofia, Bulgaria, 1527 | |
| Sofia, Bulgaria, 1606 | |
| Sofia, Bulgaria, 1309 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, New Brunswick | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Czech Republic | |
| Kolin, Czech Republic, 280 20 | |
| Uherske Hradiste, Czech Republic, 686 68 | |
| Finland | |
| Hus, Finland, 29 | |
| Lahti, Finland, 15850 | |
| Oulu, Finland, 90220 | |
| Seinäjoki, Finland, 60220 | |
| Turku, Finland, 20520 | |
| France | |
| Caen, 14, France, 14033 | |
| Toulouse Cedex 9, 31, France, 31059 | |
| Albi, France, 81000 | |
| Antony Cedex, France, 92 92166 | |
| Cholet Cedex, France, 49 49325 | |
| Paris Cedex 13, France, 75 75651 | |
| Poitiers, France, 86 86021 | |
| Pontoise, France, 95300 | |
| Strasbourg Cedex, France, 67091 | |
| Tourcoinq, France, 59208 | |
| Germany | |
| Frankfurt, HE, Germany, 60488 | |
| Bad Nauheim, Germany, HE 61231 | |
| Berlin, Germany, BE 13353 | |
| Berlin, Germany, BE 12559 | |
| Bochum, Germany, NW 44791 | |
| Essen, Germany, NW 45138 | |
| Frankfurt, Germany, HE 60590 | |
| Göttingen, Germany, NI 37075 | |
| Leipzig, Germany, 4289 | |
| Regensburg, Germany, BY 93042 | |
| Wuppertal, Germany, NW 42117 | |
| India | |
| New Delhi, Delhi, India, 110060 | |
| Bangalore, Karna, India, 562158 | |
| Pune, Mahara, India, 411004 | |
| Bangalore, India, 560034 | |
| Bikaner, India, 334003 | |
| Chennai, India, 600037 | |
| Delhi, India, 110055 | |
| Indore, India, 452018 | |
| Thrissur, India, 680002 | |
| Israel | |
| Ashkelon, Israel, 78306 | |
| Beer Yaakov, Israel, 70300 | |
| Haifa, Israel, 31096 | |
| Holon, Israel, 58100 | |
| Jerusalem, Israel, 91240 | |
| Jerusalem, Israel, 91120 | |
| Jerusalem, Israel, 91031 | |
| Kfar Saba, Israel, 44281 | |
| Nahariya, Israel, 22100 | |
| Nazareth, Israel, 16000 | |
| Petach Tikva, Israel, 49100 | |
| Safed, Israel, 13100 | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Mantova, Italy, 46100 | |
| Milano, Italy, 20162 | |
| Pavia, Italy, PV 27100 | |
| Netherlands | |
| Den Haag, Netherlands, 2512 VA | |
| Maastricht, Netherlands, 6229 HX | |
| Zwolle, Netherlands, 8011 JW | |
| Poland | |
| Koscierzyna, Poland, 83-400 | |
| Olsztyn, Poland, 10-045 | |
| Slupsk, Poland, 76-200 | |
| Tarnow, Poland, 33-100 | |
| Warszawa, Poland, 00-909 | |
| Warszawa, Poland, 04-628 | |
| Wroclaw, Poland, 51-124 | |
| Wroclaw, Poland, 50-981 | |
| Romania | |
| Bacau, Romania, 600114 | |
| Bucuresti, Romania, 22328 | |
| Bucuresti, Romania, 20125 | |
| Bucuresti, Romania, 21659 | |
| Russian Federation | |
| Barnaul, Russian Federation, 656099 | |
| Kemerovo, Russian Federation, 650002 | |
| Krasnoyarsk, Russian Federation, 660062 | |
| Moscow, Russian Federation, 127644 | |
| Moscow, Russian Federation, 123182 | |
| Moscow, Russian Federation, 127473 | |
| Moscow, Russian Federation, 125101 | |
| Moscow, Russian Federation, 113093 | |
| Novosibirsk, Russian Federation, 630090 | |
| Novosibirsk, Russian Federation, 630008 | |
| Novosibirsk, Russian Federation, 630075 | |
| Saratov, Russian Federation, 410028 | |
| St-Petersburg, Russian Federation, 198205 | |
| St-Petersburg, Russian Federation, 199106 | |
| St. Petersburg, Russian Federation, 193318 | |
| St. Petersburg, Russian Federation, 192242 | |
| Tomsk, Russian Federation, 634012 | |
| Sweden | |
| Göteborg, Sweden, 413 45 | |
| Lidköping, Sweden, 53185 | |
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 May 16, 2013