Clinical trial NCT00709865: Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Insufficiency
Congestive Heart Failure
Keywords: renal insufficiency
diuretic
congestive heart failure
acute decompensated heart failure
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
timeFrame: 0-60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Fort Smith
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Monterey Park
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Torrance
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Lombard
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Ayer
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Hyannis
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: West Springfield
country: United States
state: Massachusetts
city: Traverse City
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Lee's Summit
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Ridgewood
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Camp Hill
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Orangeburg
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Oak Ridge
country: United States
state: Tennessee
city: Tullahoma
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Whitney
country: United States
state: Texas
city: Danville
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: Buenos Aires
country: Argentina
state: BUE
city: Buenos Aires
country: Argentina
state: BUE
city: Capital Federal
country: Argentina
state: CBA
city: Corrientes
country: Argentina
state: COR
city: Cordoba
country: Argentina
state: CRD
city: Villa Cabrera
country: Argentina
state: CRD
city: Santa Fe
country: Argentina
state: SFE
city: Santa Fe
country: Argentina
state: SFE
city: San Luis
country: Argentina
state: SLS
city: Tucuman
country: Argentina
state: TUC
city: Capital Federal
country: Argentina
city: Darlinghurst
country: Australia
state: New South Wales
city: Liverpool
country: Australia
state: New South Wales
city: Canberra
country: Australia
city: Dandenong
country: Australia
city: Melbourne
country: Australia
city: Fortaleza
country: Brazil
state: CE
city: Porto Alegre
country: Brazil
state: RS
city: Aracaju
country: Brazil
state: SE
city: Santo Andre
country: Brazil
state: SP
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Campo Grande
country: Brazil
city: Curitiba
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Pazardjik
country: Bulgaria
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Vancouver
country: Canada
state: British Columbia
city: Saint John
country: Canada
state: New Brunswick
city: Kolin
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Hus
country: Finland
city: Lahti
country: Finland
city: Oulu
country: Finland
city: Seinäjoki
country: Finland
city: Turku
country: Finland
city: Albi
country: France
city: Antony cedex
country: France
city: Caen
country: France
city: Cholet Cedex
country: France
city: Paris cedex 13
country: France
city: Poitiers
country: France
city: Pontoise
country: France
city: Strasbourg Cedex
country: France
city: Toulouse Cedex 9
country: France
city: Tourcoinq
country: France
city: Frankfurt
country: Germany
state: HE
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Göttingen
country: Germany
city: Leipzig
country: Germany
city: Regensburg
country: Germany
city: Wuppertal
country: Germany
city: New Delhi
country: India
state: Delhi
city: Bangalore
country: India
state: Karna
city: Pune
country: India
state: Mahara
city: Bangalore
country: India
city: Bikaner
country: India
city: Chennai
country: India
city: Delhi
country: India
city: Indore
country: India
city: Thrissur
country: India
city: Ashkelon
country: Israel
city: Beer Yaakov
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Nahariya
country: Israel
city: Nazareth
country: Israel
city: Petach Tikva
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
city: Mantova
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Den Haag
country: Netherlands
city: Maastricht
country: Netherlands
city: Zwolle
country: Netherlands
city: Koscierzyna
country: Poland
city: Olsztyn
country: Poland
city: Slupsk
country: Poland
city: Tarnow
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
city: Bacau
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Barnaul
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Saratov
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Göteborg
country: Sweden
city: Lidköping
country: Sweden
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: