Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency
NCT ID: NCT00745316
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
34 participants
INTERVENTIONAL
2009-02-28
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study will also explore:
* Disease related quality-of-life
* Exercise capacity
* Renal function
* Concomitant medications
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
NCT00709865
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
NCT05353166
Developing Oral LT3 Therapy for Heart Failure - HFpEF
NCT04111536
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
NCT02992288
Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Preserved Ejection Fraction (Cycle-2-PEF)
NCT06215586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
oral Dose 1
Tonapofylline
Oral Tonapofylline - 2 capsules bid
2
oral Dose 2
Tonapofylline
Oral Tonapofylline - 2 capsules bid
3
oral Dose 3
Tonapofylline
Oral Tonapofylline - 2 capsules bid
4
oral Dose 4
Tonapofylline
Oral Tonapofylline - 2 capsules bid
5
oral Dose 5
Tonapofylline
Oral Tonapofylline - 2 capsules bid
6
Placebo - 2 capsules bid
Placebo
Oral placebo - 2 capsules bid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tonapofylline
Oral Tonapofylline - 2 capsules bid
Placebo
Oral placebo - 2 capsules bid
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of heart failure requiring hospitalization \>1 and ≤12 months prior to screening
* NYHA Class III or IV at the time of screening
* Renal insufficiency as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2
* Negative pregnancy test
Exclusion Criteria
* History of seizure
* History of stroke
* Serious systemic infection
* Sustained systolic blood pressure \>170 or \<90 mmHg
* Myocardial infarction within 30 days of Day 1
* Hemodynamically destabilizing arrhythmia within 30 days of Day 1
* Uncorrected hemodynamically significant primary valvular disease
* Known obstructive or restrictive cardiomyopathy
* Cardiac surgery within 60 days prior to Day 1
* Likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
* Evidence of malignancy within 6 months prior to Day 1.
* Participation in any other investigational study of drugs or devices within 30 days prior to Day 1.
* Receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
* Presence of any clinically significant condition that might interfere with optimal safe participation in this study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsville, Alabama, United States
Mobile, Alabama, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
San Diego, California, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Ormond Beach, Florida, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Lincoln, Nebraska, United States
The Bronx, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Lancaster, Pennsylvania, United States
Germantown, Tennessee, United States
Roanoke, Virginia, United States
Beloit, Wisconsin, United States
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
161HF201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.