Heart Failure Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT00709865

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 188 Locations for this study

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Huntsville Alabama, 35801, United States

Mobile Alabama, 36608, United States

Fort Smith Arkansas, 72917, United States

Beverly Hills California, 90210, United States

Chula Vista California, 91911, United States

Mission Viejo California, 92691, United States

Monterey Park California, 91754, United States

Oceanside California, 92056, United States

Redondo Beach California, 90277, United States

San Diego California, 92103, United States

Sylmar California, 91342, United States

Torrance California, 90502, United States

Yuba City California, 95991, United States

Hartford Connecticut, 06102, United States

Jacksonville Florida, 32216, United States

Sarasota Florida, 34239, United States

Tampa Florida, 33613, United States

Lombard Illinois, 60148, United States

Indianapolis Indiana, 46202, United States

Muncie Indiana, 47303, United States

Iowa City Iowa, 52242, United States

Kansas City Kansas, 64132, United States

Wichita Kansas, 67220, United States

Baltimore Maryland, 21201, United States

Ayer Massachusetts, 01432, United States

Boston Massachusetts, 02114, United States

Hyannis Massachusetts, 02601, United States

Springfield Massachusetts, 01107, United States

West Springfield Massachusetts, 01089, United States

Traverse City Michigan, 49684, United States

Minneapolis Minnesota, 55404, United States

Kansas City Missouri, 64132, United States

Lee's Summit Missouri, 64063, United States

Saint Louis Missouri, 63128, United States

Omaha Nebraska, 68131, United States

Ridgewood New Jersey, 07450, United States

Bronx New York, 10461, United States

Johnson City New York, 13790, United States

Mineola New York, 11501, United States

New York New York, 10021, United States

Stony Brook New York, 11794, United States

Concord North Carolina, 28025, United States

Cincinnati Ohio, 45267, United States

Cleveland Ohio, 44195, United States

Columbus Ohio, 43210, United States

Franklin Ohio, 45005, United States

Oklahoma City Oklahoma, 73109, United States

Oklahoma City Oklahoma, 73120, United States

Tulsa Oklahoma, 74104, United States

Portland Oregon, 97213, United States

Camp Hill Pennsylvania, 17011, United States

Danville Pennsylvania, 17822, United States

Doylestown Pennsylvania, 18901, United States

Lancaster Pennsylvania, 17603, United States

Philadelphia Pennsylvania, 19140, United States

Providence Rhode Island, 02908, United States

Orangeburg South Carolina, 29118, United States

Nashville Tennessee, 37208, United States

Oak Ridge Tennessee, 37830, United States

Tullahoma Tennessee, 37388, United States

Dallas Texas, 75216, United States

Houston Texas, 77030, United States

San Antonio Texas, 78215, United States

Whitney Texas, 76692, United States

Danville Virginia, 24541, United States

Olympia Washington, 98506, United States

Tacoma Washington, 98405, United States

Charleston West Virginia, 25304, United States

Buenos Aires BUE, B1605, Argentina

Buenos Aires BUE, B1722, Argentina

Capital Federal CBA, C1280, Argentina

Corrientes COR, W3400, Argentina

Cordoba CRD, X5004, Argentina

Villa Cabrera CRD, X5009, Argentina

Santa Fe SFE, 3000, Argentina

Santa Fe SFE, S3000, Argentina

San Luis SLS, D5702, Argentina

Tucuman TUC, 4000, Argentina

Capital Federal , C1437, Argentina

Darlinghurst New South Wales, 2010, Australia

Liverpool New South Wales, 2170, Australia

Canberra , ACT 2, Australia

Dandenong , 3175, Australia

Melbourne , 3004, Australia

Fortaleza CE, 60864, Brazil

Porto Alegre RS, 90110, Brazil

Aracaju SE, 49015, Brazil

Santo Andre SP, 09190, Brazil

Sao Jose do Rio Preto SP, 15015, Brazil

Campo Grande , 79080, Brazil

Curitiba , 80010, Brazil

Porto Alegre , 90620, Brazil

Porto Alegre , CEP 9, Brazil

Recife , 50100, Brazil

Pazardjik , 4400, Bulgaria

Pleven , 5800, Bulgaria

Sofia , 1202, Bulgaria

Sofia , 1309, Bulgaria

Sofia , 1527, Bulgaria

Sofia , 1606, Bulgaria

Vancouver British Columbia, V5Z 1, Canada

Saint John New Brunswick, E2L 4, Canada

Kolin , 280 2, Czechia

Uherske Hradiste , 686 6, Czechia

Hus , 29, Finland

Lahti , 15850, Finland

Oulu , 90220, Finland

Seinäjoki , 60220, Finland

Turku , 20520, Finland

Albi , 81000, France

Antony cedex , 92 92, France

Caen , 14033, France

Cholet Cedex , 49 49, France

Paris cedex 13 , 75 75, France

Poitiers , 86 86, France

Pontoise , 95300, France

Strasbourg Cedex , 67091, France

Toulouse Cedex 9 , 31059, France

Tourcoinq , 59208, France

Frankfurt HE, 60488, Germany

Bad Nauheim , HE 61, Germany

Berlin , BE 12, Germany

Berlin , BE 13, Germany

Bochum , NW 44, Germany

Essen , NW 45, Germany

Frankfurt , HE 60, Germany

Göttingen , NI 37, Germany

Leipzig , 4289, Germany

Regensburg , BY 93, Germany

Wuppertal , NW 42, Germany

New Delhi Delhi, 11006, India

Bangalore Karna, 56215, India

Pune Mahara, 41100, India

Bangalore , 56003, India

Bikaner , 33400, India

Chennai , 60003, India

Delhi , 11005, India

Indore , 45201, India

Thrissur , 68000, India

Ashkelon , 78306, Israel

Beer Yaakov , 70300, Israel

Haifa , 31096, Israel

Holon , 58100, Israel

Jerusalem , 91031, Israel

Jerusalem , 91120, Israel

Jerusalem , 91240, Israel

Kfar Saba , 44281, Israel

Nahariya , 22100, Israel

Nazareth , 16000, Israel

Petach Tikva , 49100, Israel

Safed , 13100, Israel

Tel Aviv , 64239, Israel

Mantova , 46100, Italy

Milano , 20162, Italy

Pavia , PV 27, Italy

Den Haag , 2512 , Netherlands

Maastricht , 6229 , Netherlands

Zwolle , 8011 , Netherlands

Koscierzyna , 83-40, Poland

Olsztyn , 10-04, Poland

Slupsk , 76-20, Poland

Tarnow , 33-10, Poland

Warszawa , 00-90, Poland

Warszawa , 04-62, Poland

Wroclaw , 50-98, Poland

Wroclaw , 51-12, Poland

Bacau , 60011, Romania

Bucuresti , 20125, Romania

Bucuresti , 21659, Romania

Bucuresti , 22328, Romania

Barnaul , 65609, Russian Federation

Kemerovo , 65000, Russian Federation

Krasnoyarsk , 66006, Russian Federation

Moscow , 11309, Russian Federation

Moscow , 12318, Russian Federation

Moscow , 12510, Russian Federation

Moscow , 12747, Russian Federation

Moscow , 12764, Russian Federation

Novosibirsk , 63000, Russian Federation

Novosibirsk , 63007, Russian Federation

Novosibirsk , 63009, Russian Federation

Saratov , 41002, Russian Federation

St-Petersburg , 19820, Russian Federation

St-Petersburg , 19910, Russian Federation

St. Petersburg , 19224, Russian Federation

St. Petersburg , 19331, Russian Federation

Tomsk , 63401, Russian Federation

Göteborg , 413 4, Sweden

Lidköping , 53185, Sweden

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT00709865

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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