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Tracking Information | |
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First Received Date † | June 4, 2007 |
Last Updated Date | June 4, 2007 |
Start Date † | January 2007 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | No Changes Posted |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Safety and Pharmacodynamic Study of CD-NP |
Official Title † | A Phase I, Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP |
Brief Summary | The primary objective of this study is to establish the safety of CD-NP in normal human volunteers. |
Detailed Description | 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 Phase | Phase I |
Study Type † | Interventional |
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Condition † | Heart Failure, Congestive |
Intervention † | Drug: CD-NP |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 22 |
Completion Date | May 2007 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 60 Years |
Accepts Healthy Volunteers | Yes |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00482937 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Nile Therapeutics |
Collaborators †† | |
Investigators † | |
Information Provided By | Nile Therapeutics |
Verification Date | June 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |