Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

Last updated: September 4, 2023
Sponsor: Biogen
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Kidney Disease

Chest Pain

Treatment

Placebo

tonapofylline

Clinical Study ID

NCT00709865
160HF301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previous diagnosis of heart failure.
  • Must have ADHF, requiring hospitalization, with clinical evidence for volume overload

Exclusion

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 Obstructiveor 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 daysprior to Screening
  • Nursing mothers, pregnant women, or women planning on becoming pregnant during thestudy
  • Presence of any clinically significant condition that might interfere with optimalsafe participation in this study

Study Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 31, 2008
Estimated Completion Date:
December 31, 2009

Connect with a study center

  • Buenos Aires, BUE B1605DSX
    Argentina

    Site Not Available

  • Capital Federal, CBA C1280AEB
    Argentina

    Site Not Available

  • Corrientes, COR W3400AMZ
    Argentina

    Site Not Available

  • Cordoba, CRD X5004CDT
    Argentina

    Site Not Available

  • Villa Cabrera, CRD X5009BSN
    Argentina

    Site Not Available

  • Santa Fe, SFE S3000FUJ
    Argentina

    Site Not Available

  • San Luis, SLS D5702JRS
    Argentina

    Site Not Available

  • Tucuman, TUC 4000
    Argentina

    Site Not Available

  • Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Canberra, ACT 2605
    Australia

    Site Not Available

  • Dandenong, 3175
    Australia

    Site Not Available

  • Melbourne, 3004
    Australia

    Site Not Available

  • Fortaleza, CE 60864-190
    Brazil

    Site Not Available

  • Aracaju, SE 49015-400
    Brazil

    Site Not Available

  • Santo Andre, SP 09190-610
    Brazil

    Site Not Available

  • Sao Jose do Rio Preto, SP 15015-210
    Brazil

    Site Not Available

  • Campo Grande, 79080-190
    Brazil

    Site Not Available

  • Curitiba, 80010-030
    Brazil

    Site Not Available

  • Porto Alegre, 90620-001
    Brazil

    Site Not Available

  • Recife, 50100-010
    Brazil

    Site Not Available

  • Pazardjik, 4400
    Bulgaria

    Site Not Available

  • Pleven, 5800
    Bulgaria

    Site Not Available

  • Sofia, 1309
    Bulgaria

    Site Not Available

  • Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Saint John, New Brunswick E2L 4L2
    Canada

    Site Not Available

  • Kolin, 280 20
    Czech Republic

    Site Not Available

  • Uherske Hradiste, 686 68
    Czech Republic

    Site Not Available

  • Kolin, 280 20
    Czechia

    Site Not Available

  • Uherske Hradiste, 686 68
    Czechia

    Site Not Available

  • Hus, 29
    Finland

    Site Not Available

  • Lahti, 15850
    Finland

    Site Not Available

  • Oulu, 90220
    Finland

    Site Not Available

  • empty

    Seinäjoki, 60220
    Finland

    Site Not Available

  • Seinäjoki, 60220
    Finland

    Site Not Available

  • Turku, 20520
    Finland

    Site Not Available

  • Albi, 81000
    France

    Site Not Available

  • Antony cedex, 92 92166
    France

    Site Not Available

  • Caen, 14033
    France

    Site Not Available

  • Cholet Cedex, 49 49325
    France

    Site Not Available

  • Paris cedex 13, 75 75651
    France

    Site Not Available

  • Poitiers, 86 86021
    France

    Site Not Available

  • Pontoise, 95300
    France

    Site Not Available

  • Strasbourg Cedex, 67091
    France

    Site Not Available

  • Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Tourcoinq, 59208
    France

    Site Not Available

  • Frankfurt, HE 60488
    Germany

    Site Not Available

  • Bad Nauheim, HE 61231
    Germany

    Site Not Available

  • Berlin, BE 13353
    Germany

    Site Not Available

  • Bochum, NW 44791
    Germany

    Site Not Available

  • Essen, NW 45138
    Germany

    Site Not Available

  • empty

    Göttingen, NI 37075
    Germany

    Site Not Available

  • Göttingen, NI 37075
    Germany

    Site Not Available

  • Leipzig, 4289
    Germany

    Site Not Available

  • Regensburg, BY 93042
    Germany

    Site Not Available

  • Wuppertal, NW 42117
    Germany

    Site Not Available

  • New Delhi, Delhi 110060
    India

    Site Not Available

  • Bangalore, Karna 562158
    India

    Site Not Available

  • Pune, Mahara 411004
    India

    Site Not Available

  • Bikaner, 334003
    India

    Site Not Available

  • Chennai, 600037
    India

    Site Not Available

  • Delhi, 110055
    India

    Site Not Available

  • Indore, 452018
    India

    Site Not Available

  • Thrissur, 680002
    India

    Site Not Available

  • Ashkelon, 78306
    Israel

    Site Not Available

  • Beer Yaakov, 70300
    Israel

    Site Not Available

  • Haifa, 31096
    Israel

    Site Not Available

  • Holon, 58100
    Israel

    Site Not Available

  • Jerusalem, 91031
    Israel

    Site Not Available

  • Kfar Saba, 44281
    Israel

    Site Not Available

  • Nahariya, 22100
    Israel

    Site Not Available

  • Nazareth, 16000
    Israel

    Site Not Available

  • Petach Tikva, 49100
    Israel

    Site Not Available

  • Safed, 13100
    Israel

    Site Not Available

  • Tel Aviv, 64239
    Israel

    Site Not Available

  • Mantova, 46100
    Italy

    Site Not Available

  • Milano, 20162
    Italy

    Site Not Available

  • Pavia, PV 27100
    Italy

    Site Not Available

  • Den Haag, 2512 VA
    Netherlands

    Site Not Available

  • Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Zwolle, 8011 JW
    Netherlands

    Site Not Available

  • Koscierzyna, 83-400
    Poland

    Site Not Available

  • Olsztyn, 10-045
    Poland

    Site Not Available

  • Slupsk, 76-200
    Poland

    Site Not Available

  • Tarnow, 33-100
    Poland

    Site Not Available

  • Warszawa, 00-909
    Poland

    Site Not Available

  • Wroclaw, 51-124
    Poland

    Site Not Available

  • Bacau, 600114
    Romania

    Site Not Available

  • Bucuresti, 21659
    Romania

    Site Not Available

  • Barnaul, 656099
    Russian Federation

    Site Not Available

  • Kemerovo, 650002
    Russian Federation

    Site Not Available

  • Krasnoyarsk, 660062
    Russian Federation

    Site Not Available

  • Moscow, 113093
    Russian Federation

    Site Not Available

  • Novosibirsk, 630090
    Russian Federation

    Site Not Available

  • Saratov, 410028
    Russian Federation

    Site Not Available

  • St-Petersburg, 199106
    Russian Federation

    Site Not Available

  • St. Petersburg, 193318
    Russian Federation

    Site Not Available

  • Tomsk, 634012
    Russian Federation

    Site Not Available

  • empty

    Göteborg, 413 45
    Sweden

    Site Not Available

  • Göteborg, 413 45
    Sweden

    Site Not Available

  • empty

    Lidköping, 53185
    Sweden

    Site Not Available

  • Lidköping, 53185
    Sweden

    Site Not Available

  • Huntsville, Alabama 35801
    United States

    Site Not Available

  • Mobile, Alabama 36608
    United States

    Site Not Available

  • Fort Smith, Arkansas 72917
    United States

    Site Not Available

  • empty

    Ft. Smith, Arkansas 72917
    United States

    Site Not Available

  • Beverly Hills, California 90210
    United States

    Site Not Available

  • Chula Vista, California 91911
    United States

    Site Not Available

  • empty

    Mission Viego, California 92691
    United States

    Site Not Available

  • Mission Viejo, California 92691
    United States

    Site Not Available

  • Monterey Park, California 91754
    United States

    Site Not Available

  • Oceanside, California 92056
    United States

    Site Not Available

  • Redondo Beach, California 90277
    United States

    Site Not Available

  • San Diego, California 92103
    United States

    Site Not Available

  • Sylmar, California 91342
    United States

    Site Not Available

  • Torrance, California 90502
    United States

    Site Not Available

  • Yuba City, California 95991
    United States

    Site Not Available

  • Hartford, Connecticut 06102
    United States

    Site Not Available

  • Jacksonville, Florida 32216
    United States

    Site Not Available

  • Sarasota, Florida 34239
    United States

    Site Not Available

  • Tampa, Florida 33613
    United States

    Site Not Available

  • Lombard, Illinois 60148
    United States

    Site Not Available

  • Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Muncie, Indiana 47303
    United States

    Site Not Available

  • Iowa City, Iowa 52242
    United States

    Site Not Available

  • Kansas City, Kansas 64132
    United States

    Site Not Available

  • Wichita, Kansas 67220
    United States

    Site Not Available

  • Baltimore, Maryland 21201
    United States

    Site Not Available

  • Ayer, Massachusetts 01432
    United States

    Site Not Available

  • Boston, Massachusetts 02114
    United States

    Site Not Available

  • Hyannis, Massachusetts 02601
    United States

    Site Not Available

  • Springfield, Massachusetts 01107
    United States

    Site Not Available

  • West Springfield, Massachusetts 01089
    United States

    Site Not Available

  • Traverse City, Michigan 49684
    United States

    Site Not Available

  • Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Lee's Summit, Missouri 64063
    United States

    Site Not Available

  • Saint Louis, Missouri 63128
    United States

    Site Not Available

  • empty

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Omaha, Nebraska 68131
    United States

    Site Not Available

  • Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Bronx, New York 10461
    United States

    Site Not Available

  • Johnson City, New York 13790
    United States

    Site Not Available

  • Mineola, New York 11501
    United States

    Site Not Available

  • New York, New York 10021
    United States

    Site Not Available

  • empty

    New York City, New York 10021
    United States

    Site Not Available

  • Stony Brook, New York 11794
    United States

    Site Not Available

  • Concord, North Carolina 28025
    United States

    Site Not Available

  • Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland, Ohio 44195
    United States

    Site Not Available

  • Columbus, Ohio 43210
    United States

    Site Not Available

  • Franklin, Ohio 45005
    United States

    Site Not Available

  • Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Portland, Oregon 97213
    United States

    Site Not Available

  • Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • empty

    Camphill, Pennsylvania 17011
    United States

    Site Not Available

  • Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Doylestown, Pennsylvania 18901
    United States

    Site Not Available

  • Lancaster, Pennsylvania 17603
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Providence, Rhode Island 02908
    United States

    Site Not Available

  • Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Nashville, Tennessee 37208
    United States

    Site Not Available

  • Oak Ridge, Tennessee 37830
    United States

    Site Not Available

  • Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Dallas, Texas 75216
    United States

    Site Not Available

  • Houston, Texas 77030
    United States

    Site Not Available

  • San Antonio, Texas 78215
    United States

    Site Not Available

  • Whitney, Texas 76692
    United States

    Site Not Available

  • Olympia, Washington 98506
    United States

    Site Not Available

  • Tacoma, Washington 98405
    United States

    Site Not Available

  • Charleston, West Virginia 25304
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.