Heart Failure, Congestive Clinical Trial
Official title:
A Phase I, Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP
The primary objective of this study is to establish the safety of CD-NP in normal human volunteers.
The study will be conducted in two phases. The first phase, “ascending dose phase”, will be
an open-label study in cohorts of four (4) subjects (entered two subjects at a time) with
the primary objective of establishing the safety of CD-NP. The second phase, “MTD
confirmation phase”, will be conducted under randomized, double-blind, placebo-controlled
conditions in a larger cohort of subjects (10 subjects). The primary objective of this phase
will be to confirm the safety and pharmacodynamic findings at the apparent MTD.
Secondary objectives include evaluation of the effect of CD-NP on: mean arterial pressure
(MAP), heart rate (HR), urinary sodium and potassium excretion (UNaV and UKV, respectively),
urinary flow rate (UV), and creatinine clearance. Plasma concentrations of CD-NP,
angiotensin II, and aldosterone, and the urinary excretion rates of cGMP and CD-NP will also
be determined.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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