Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04095793|
Recruitment Status : Terminated (Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.)
First Posted : September 19, 2019
Results First Posted : November 30, 2022
Last Update Posted : November 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Neurogenic Orthostatic Hypotension||Drug: ampreloxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure|
|Actual Study Start Date :||September 19, 2019|
|Actual Primary Completion Date :||November 12, 2021|
|Actual Study Completion Date :||November 12, 2021|
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Oral tablet, QD
Other Name: TD-9855
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to a maximum of 749 days ]
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.
Clinically significant abnormalities in physical and neurological examinations, vital signs, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs.
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): NCT04095793
|Study Director:||Medical Monitor||Theravance Biopharma|