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TRIDENT-1: Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00709865
Collaborator
(none)
420
Enrollment
189
Locations
4
Arms
17
Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

.03 mg/kg

Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928

    		•
    Experimental: 2

    .15 mg/kg

    Drug: tonapofylline
    IV
    Other Names:
  • Adentri
  • BG9928

    		•
    Experimental: 3

    .3 mg/kg

    Drug: tonapofylline
    IV
    Other Names:
  • Adentri
  • BG9928

    		•
    Placebo Comparator: 4

    Placebo

    Drug: Placebo
    IV

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Huntsville Alabama United States 35801
    2 Mobile Alabama United States 36608
    3 Ft. Smith Arkansas United States 72917
    4 Beverly Hills California United States 90210
    5 Chula Vista California United States 91911
    6 Mission Viego California United States 92691
    7 Monterey Park California United States 91754
    8 Oceanside California United States 92056
    9 Redondo Beach California United States 90277
    10 San Diego California United States 92103
    11 Sylmar California United States 91342
    12 Torrance California United States 90502
    13 Yuba City California United States 95991
    14 Hartford Connecticut United States 6102
    15 Jacksonville Florida United States 32216
    16 Sarasota Florida United States 34239
    17 Tampa Florida United States 33613
    18 Lombard Illinois United States 60148
    19 Indianapolis Indiana United States 46202
    20 Muncie Indiana United States 47303
    21 Iowa City Iowa United States 52242
    22 Kansas City Kansas United States 64132
    23 Wichita Kansas United States 67220
    24 Baltimore Maryland United States 21201
    25 Ayer Massachusetts United States 01432
    26 Boston Massachusetts United States 02114
    27 Hyannis Massachusetts United States 02601
    28 Springfield Massachusetts United States 01107
    29 West Springfield Massachusetts United States 01089
    30 Traverse City Michigan United States 49684
    31 Minneapolis Minnesota United States 55404
    32 Kansas City Missouri United States 64132
    33 Lee's Summit Missouri United States 64063
    34 St. Louis Missouri United States 63128
    35 Omaha Nebraska United States 68131
    36 Ridgewood New Jersey United States 07450
    37 Bronx New York United States 10461
    38 Johnson City New York United States 13790
    39 Mineola New York United States 11501
    40 New York City New York United States 10021
    41 Stony Brook New York United States 11794
    42 Concord North Carolina United States 28025
    43 Cincinnati Ohio United States 45267
    44 Cleveland Ohio United States 44195
    45 Columbus Ohio United States 43210
    46 Franklin Ohio United States 45005
    47 Oklahoma City Oklahoma United States 73109
    48 Oklahoma City Oklahoma United States 73120
    49 Tulsa Oklahoma United States 74104
    50 Portland Oregon United States 97213
    51 Camphill Pennsylvania United States 17011
    52 Danville Pennsylvania United States 17822
    53 Doylestown Pennsylvania United States 18901
    54 Lancaster Pennsylvania United States 17603
    55 Philadelphia Pennsylvania United States 19140
    56 Providence Rhode Island United States 02908
    57 Orangeburg South Carolina United States 29118
    58 Nashville Tennessee United States 37208
    59 Oak Ridge Tennessee United States 37830
    60 Tullahoma Tennessee United States 37388
    61 Dallas Texas United States 75216
    62 Houston Texas United States 77030
    63 San Antonio Texas United States 78215
    64 Whitney Texas United States 76692
    65 Danville Virginia United States 24541
    66 Olympia Washington United States 98506
    67 Tacoma Washington United States 98405
    68 Charleston West Virginia United States 25304
    69 Buenos Aires BUE Argentina B1605DSX
    70 Buenos Aires BUE Argentina B1722COV
    71 Capital Federal CBA Argentina C1280AEB
    72 Corrientes COR Argentina W3400AMZ
    73 Cordoba CRD Argentina X5004CDT
    74 Villa Cabrera CRD Argentina X5009BSN
    75 Santa Fe SFE Argentina 3000
    76 Santa Fe SFE Argentina S3000FUJ
    77 San Luis SLS Argentina D5702JRS
    78 Tucuman TUC Argentina 4000
    79 Capital Federal Argentina C1437JCP
    80 Darlinghurst New South Wales Australia 2010
    81 Liverpool New South Wales Australia 2170
    82 Canberra Australia ACT 2605
    83 Dandenong Australia 3175
    84 Melbourne Australia 3004
    85 Fortaleza CE Brazil 60864-190
    86 Porto Alegre RS Brazil 90110-270
    87 Aracaju SE Brazil 49015-400
    88 Santo Andre SP Brazil 09190-610
    89 Sao Jose do Rio Preto SP Brazil 15015-210
    90 Campo Grande Brazil 79080-190
    91 Curitiba Brazil 80010-030
    92 Porto Alegre Brazil 90620-001
    93 Porto Alegre Brazil CEP 90350-200
    94 Recife Brazil 50100-010
    95 Pazardjik Bulgaria 4400
    96 Pleven Bulgaria 5800
    97 Sofia Bulgaria 1202
    98 Sofia Bulgaria 1309
    99 Sofia Bulgaria 1527
    100 Sofia Bulgaria 1606
    101 Vancouver British Columbia Canada V5Z 1M9
    102 Saint John New Brunswick Canada E2L 4L2
    103 Kolin Czech Republic 280 20
    104 Uherske Hradiste Czech Republic 686 68
    105 Hus Finland 29
    106 Lahti Finland 15850
    107 Oulu Finland 90220
    108 Seinäjoki Finland 60220
    109 Turku Finland 20520
    110 Albi France 81000
    111 Antony cedex France 92 92166
    112 Caen France 14033
    113 Cholet Cedex France 49 49325
    114 Paris cedex 13 France 75 75651
    115 Poitiers France 86 86021
    116 Pontoise France 95300
    117 Strasbourg Cedex France 67091
    118 Toulouse Cedex 9 France 31059
    119 Tourcoinq France 59208
    120 Frankfurt HE Germany 60488
    121 Bad Nauheim Germany HE 61231
    122 Berlin Germany BE 12559
    123 Berlin Germany BE 13353
    124 Bochum Germany NW 44791
    125 Essen Germany NW 45138
    126 Frankfurt Germany HE 60590
    127 Göttingen Germany NI 37075
    128 Leipzig Germany 4289
    129 Regensburg Germany BY 93042
    130 Wuppertal Germany NW 42117
    131 New Delhi Delhi India 110060
    132 Bangalore Karna India 562158
    133 Pune Mahara India 411004
    134 Bangalore India 560034
    135 Bikaner India 334003
    136 Chennai India 600037
    137 Delhi India 110055
    138 Indore India 452018
    139 Thrissur India 680002
    140 Ashkelon Israel 78306
    141 Beer Yaakov Israel 70300
    142 Haifa Israel 31096
    143 Holon Israel 58100
    144 Jerusalem Israel 91031
    145 Jerusalem Israel 91120
    146 Jerusalem Israel 91240
    147 Kfar Saba Israel 44281
    148 Nahariya Israel 22100
    149 Nazareth Israel 16000
    150 Petach Tikva Israel 49100
    151 Safed Israel 13100
    152 Tel Aviv Israel 64239
    153 Mantova Italy 46100
    154 Milano Italy 20162
    155 Pavia Italy PV 27100
    156 Den Haag Netherlands 2512 VA
    157 Maastricht Netherlands 6229 HX
    158 Zwolle Netherlands 8011 JW
    159 Koscierzyna Poland 83-400
    160 Olsztyn Poland 10-045
    161 Slupsk Poland 76-200
    162 Tarnow Poland 33-100
    163 Warszawa Poland 00-909
    164 Warszawa Poland 04-628
    165 Wroclaw Poland 50-981
    166 Wroclaw Poland 51-124
    167 Bacau Romania 600114
    168 Bucuresti Romania 20125
    169 Bucuresti Romania 21659
    170 Bucuresti Romania 22328
    171 Barnaul Russian Federation 656099
    172 Kemerovo Russian Federation 650002
    173 Krasnoyarsk Russian Federation 660062
    174 Moscow Russian Federation 113093
    175 Moscow Russian Federation 123182
    176 Moscow Russian Federation 125101
    177 Moscow Russian Federation 127473
    178 Moscow Russian Federation 127644
    179 Novosibirsk Russian Federation 630008
    180 Novosibirsk Russian Federation 630075
    181 Novosibirsk Russian Federation 630090
    182 Saratov Russian Federation 410028
    183 St-Petersburg Russian Federation 198205
    184 St-Petersburg Russian Federation 199106
    185 St. Petersburg Russian Federation 192242
    186 St. Petersburg Russian Federation 193318
    187 Tomsk Russian Federation 634012
    188 Göteborg Sweden 413 45
    189 Lidköping Sweden 53185

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT00709865
    Other Study ID Numbers:
    • 160HF301
    First Posted:
    Jul 3, 2008
    Last Update Posted:
    Jan 12, 2016
    Last Verified:
    Dec 1, 2015
    Keywords provided by Biogen
    renal insufficiency
    diuretic
    congestive heart failure
    acute decompensated heart failure
    Additional relevant MeSH terms:
    Renal Insufficiency
    Heart Failure
    1,3-dipropyl-8-(2-(5,6-epoxy)norbornyl)xanthine

    Study Results

    No Results Posted as of Jan 12, 2016