Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) (NOH304)
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ClinicalTrials.gov Identifier: NCT01132326 |
Recruitment Status
:
Completed
First Posted
: May 28, 2010
Results First Posted
: April 21, 2014
Last Update Posted
: March 15, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | September 9, 2009 | |||
First Posted Date ICMJE | May 28, 2010 | |||
Results First Submitted Date | March 18, 2014 | |||
Results First Posted Date | April 21, 2014 | |||
Last Update Posted Date | March 15, 2017 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Patients With Treatment-emergent Adverse Events [ Time Frame: up to 2 years ] Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study
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Original Primary Outcome Measures ICMJE |
The occurrence of treatment-emergent adverse events and specific evaluation of blood pressure, heart rate, and laboratory findings across the study. [ Time Frame: Anticipated maximum of 2 years duration for study ] | |||
Change History | Complete list of historical versions of study NCT01132326 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) | |||
Official Title ICMJE | A Multi-center, Open-label Study to Assess the Long-term Safety of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension | |||
Brief Summary | Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge resulting in symptomatic cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of NOH. The present study will evaluate the long-term safety of droxidopa. | |||
Detailed Description | This is a Phase III, multi-center, open-label study designed to evaluate the long-term safety of droxidopa in subjects with neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathy. Patients will be initially treated with droxidopa at their individualized dose identified during the titration phase in Protocol 301. Patients will not require adjustment of their dose, unless their physician feels a dose change will benefit their symptoms, or side effects. At any point in the study a patient's physician may elect to titrate the subject to a higher or lower dose if they feel additional benefit can be safely derived or to deal with any unwanted side-effect. Patients will return to the clinic for study visits at 1, 3, 6, 9 and 12 months (± 1 week allowed for 1 month visit, ± 2 weeks allowed for subsequent study visits). Patients who prematurely withdraw from the study will be asked to attend the study center for a final assessment At the conclusion of the 12 month treatment period, all patients who benefit from treatment with droxidopa will be offered the option to continue to receive open-label droxidopa through a separate access program. At any time during the study, patients can schedule a visit with their study physician if they experience a worsening of symptoms and wish to have their dose adjusted or to remove themselves from the trial. Patients who decide to terminate their participation in the study will receive a phone call 1 month after leaving the trial to follow-up on any new or ongoing adverse events (AEs). It is a recognized best practice that patients with neurogenic orthostatic hypotension are advised not to lay fully supine because of the associated increased risk of supine hypertension inherent with their condition. Patients participating in this study should be advised to sleep in a semi-recumbent position. . Patients will attend the study center as out-patients. Patients will be identified using the unique identification number assigned during Protocol 301. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Droxidopa
Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
Other Names:
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Study Arms | Experimental: Droxidopa
Open-Label Droxidopa
Intervention: Drug: Droxidopa |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
350 | |||
Original Estimated Enrollment ICMJE |
118 | |||
Actual Study Completion Date | February 2013 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: To be eligible for inclusion, each patient must fulfill the following criteria:
Exclusion Criteria: Patients are not eligible for this study if they fulfill one or more of the following criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01132326 | |||
Other Study ID Numbers ICMJE | Droxidopa NOH304 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Chelsea Therapeutics | |||
Study Sponsor ICMJE | Chelsea Therapeutics | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Chelsea Therapeutics | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |