Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0520
Source ID: NCT01468259
Associated Drug: Droxidopa
Title: A Multi-Center, Open-Label Study
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Renal Disease|End Stage Renal Disease
Interventions: DRUG: Droxidopa
Outcome Measures: Primary: Primary Objective Pharmacokinetic profile, The primary objective of this study is to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single oral dose compared to matched healthy subjects with normal renal function. The PK parameters Cmax, Tmax, AUC(inf), CL/F, Vz/F, t½, and CLr are considered the primary parameters for evaluation., before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours | Secondary: Secondary Objective Safety and tolerability, The secondary objective of this study is to assess the safety and tolerability of Droxidopa in matched healthy subjects and those with mild to severe renal dysfunction and ESRD through participant AEs and laboratory measures., before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours
Sponsor/Collaborators: Sponsor: Chelsea Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-10
Completion Date: 2012-12
Results First Posted:
Last Update Posted: 2013-03-29
Locations: NOCCR, Knoxville, Tennessee, 37920, United States
URL: https://clinicaltrials.gov/show/NCT01468259