BG9928 in Patients with Heart Failure and Renal Insufficiency
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral BG9928 in Patients with Heart Failure and Renal Insufficiency
IRAS ID
24507
Contact name
John G F Cleland
Contact email
Sponsor organisation
Biogen Idec
Eudract number
2007-005721-30
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This research is funded by Biogen Idec Inc and has been designed to test the safety and tolerability of BG9928 (study drug) in the treatment of heart failure in association with renal insufficiency.
Heart failure (HF) is the term used when the heart becomes less efficient at pumping blood round the body. It usually occurs because the heart muscle is damaged, reducing the pumping efficiency of the heart, causing salt and water retention and symptoms such as breathlessness, ankle swelling and reduced exercise capacity. This results, in turn, in a diminished quality of life. Death may ensue either from progressive heart failure or sudden death due to arrhythmias or vascular events. The average life expectancy of a patient with heart and renal dysfunction who has had a recent hospitalisation for heart failure is <50%.
Approximately 300 subjects will be randomised into 6 treatment groups in a 1:1:1:1:1:1 ratio (50 subjects per group) to receive either placebo, or, BG9928 7.5 mg once daily, 15 mg once daily, 75 mg once daily, 7.5 mg twice daily or 37.5 mg twice daily. Study drug will be given for 12 weeks. All study treatment is in addition to the subject’s standard care for heart failure.
The study involves a screening period that may last up to 28 days. Patients will then enter the treatment phase which lasts 12 weeks with assessments performed at Day 1, Weeks 2, 4, 8 and 12. Finally, there will be a follow-up assessment 4 weeks after the last dose of study drug.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
09/H0907/62
Date of REC Opinion
26 Oct 2009
REC opinion
Further Information Favourable Opinion