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news.Nile Therapeutics, has announced that Mayo Clinic has initiated a Phase Ib, double-blind, placebo-controlled clinical study of CD-NP, a novel chimeric natriuretic peptide, in development for the treatment of acute decompensated heart failure.
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The primary objective of Mayo’s study is to assess renal, neurohumoral and non-invasive hemodynamic physiologic parameters of intravenous infusions of CD-NP in patients with heart failure.
Key assessments include glomerular filtration rate, tubular function, renal plasma flow, urine output, mean arterial pressure, and various biomarkers. The trial is expected to enroll 27 heart failure patients.
In parallel with Mayo’s Phase Ib study, Nile is currently dosing Phase Ib and Phase IIa studies of CD-NP in heart failure patients. The primary objective of the Phase Ib study is to assess the safety and tolerability of intravenous infusions of CD-NP in patients with heart failure.
The primary objective of the Phase IIa study is to assess hemodynamic effects of intravenous infusions of CD-NP in patients with heart failure. Results from Nile’s Phase Ib and Phase IIa trials are expected to be available in 2008.
Peter Strumph, CEO of Nile, said: “We are delighted that dosing has begun in this important Phase Ib study of CD-NP in patients with heart failure. This Mayo sponsored study, which is the fourth clinical study of CD-NP, will enable us to continue to build on our understanding of the clinical effects of CD-NP.”