Safety and Pharmacodynamic Study of CD-NP
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|ClinicalTrials.gov Identifier: NCT00482937|
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : June 6, 2007
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Drug: CD-NP||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP|
|Study Start Date :||January 2007|
|Actual Study Completion Date :||May 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482937
|United States, Minnesota|
|DaVita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|