Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
NCT ID: NCT00709865
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2008-07-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
.03 mg/kg
tonapofylline
IV
2
.15 mg/kg
tonapofylline
IV
3
.3 mg/kg
tonapofylline
IV
4
Placebo
Placebo
IV
Interventions
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tonapofylline
IV
Placebo
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Tomsk, , Russia
Gothenburg, , Sweden
Lidköping, , Sweden
Huntsville, Alabama, United States
Mobile, Alabama, United States
Fort Smith, Arkansas, United States
Beverly Hills, California, United States
Chula Vista, California, United States
Mission Viejo, California, United States
Monterey Park, California, United States
Oceanside, California, United States
Redondo Beach, California, United States
San Diego, California, United States
Sylmar, California, United States
Torrance, California, United States
Yuba City, California, United States
Hartford, Connecticut, United States
Jacksonville, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Lombard, Illinois, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Ayer, Massachusetts, United States
Boston, Massachusetts, United States
Hyannis, Massachusetts, United States
Springfield, Massachusetts, United States
West Springfield, Massachusetts, United States
Traverse City, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Ridgewood, New Jersey, United States
Johnson City, New York, United States
Mineola, New York, United States
New York, New York, United States
Stony Brook, New York, United States
The Bronx, New York, United States
Concord, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Franklin, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Camp Hill, Pennsylvania, United States
Danville, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Orangeburg, South Carolina, United States
Nashville, Tennessee, United States
Oak Ridge, Tennessee, United States
Tullahoma, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Whitney, Texas, United States
Danville, Virginia, United States
Olympia, Washington, United States
Tacoma, Washington, United States
Charleston, West Virginia, United States
Buenos Aires, BUE, Argentina
Buenos Aires, BUE, Argentina
Capital Federal, CBA, Argentina
Corrientes, COR, Argentina
Córdoba, CRD, Argentina
Villa Cabrera, CRD, Argentina
Santa Fe, SFE, Argentina
Santa Fe, SFE, Argentina
San Luis, SLS, Argentina
San Miguel de Tucumán, TUC, Argentina
Capital Federal, , Argentina
Darlinghurst, New South Wales, Australia
Liverpool, New South Wales, Australia
Canberra, , Australia
Dandenong, , Australia
Melbourne, , Australia
Fortaleza, Ceará, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Aracaju, Sergipe, Brazil
Santo André, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
Campo Grande, , Brazil
Curitiba, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Pazardzhik, , Bulgaria
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Vancouver, British Columbia, Canada
Saint John, New Brunswick, Canada
Kolín, , Czechia
Uherské Hradiště, , Czechia
Hus, , Finland
Lahti, , Finland
Oulu, , Finland
Seinäjoki, , Finland
Turku, , Finland
Albi, , France
Antony, , France
Caen, , France
Cholet, , France
Paris, , France
Poitiers, , France
Pontoise, , France
Strasbourg, , France
Toulouse, , France
Tourcoinq, , France
Frankfurt am Main, Hesse, Germany
Bad Nauheim, , Germany
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Essen, , Germany
Frankfurt, , Germany
Göttingen, , Germany
Leipzig, , Germany
Regensburg, , Germany
Wuppertal, , Germany
Bangalore, Karna, India
Pune, Mahara, India
New Delhi, National Capital Territory of Delhi, India
Bangalore, , India
Bikaner, , India
Chennai, , India
Delhi, , India
Indore, , India
Thrissur, , India
Ashkelon, , Israel
Beer Yaakov, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Nazareth, , Israel
Petah Tikva, , Israel
Safed, , Israel
Tel Aviv, , Israel
Mantova, , Italy
Milan, , Italy
Pavia, , Italy
Maastricht, , Netherlands
The Hague, , Netherlands
Zwolle, , Netherlands
Kościerzyna, , Poland
Olsztyn, , Poland
Słupsk, , Poland
Tarnów, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Bacau, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Barnaul, , Russia
Kemerovo, , Russia
Krasnoyarsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Countries
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Other Identifiers
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160HF301
Identifier Type: -
Identifier Source: org_study_id
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