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Clinical Trial Summary

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure


Clinical Trial Description

Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL) treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension safety study)). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03829657
Study type Interventional
Source Theravance Biopharma
Contact
Status Terminated
Phase Phase 3
Start date February 22, 2019
Completion date November 10, 2021

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