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
  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

  Hide Study Locations
Locations
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 April 22, 2014