A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of a new therapy
The purpose of this study is to determine whether a study medication can relieve the symptoms of neurogenic orthostatic hypotension (NOH) and whether it causes any side effects in people with symptomatic NOH. It is anticipated that 450 subjects will participate in this study at approximately 100 centers (at least four at Rush University Medical Center). If you agree and are eligible to participate, your participation may last up to 23 weeks and you will be asked to come to the Medical Center nine to 12 times for study visits. The study consists of three phases: an open-label dose finding phase (up to two weeks) where you will receive active study drug; a washout phase (two to three weeks) where you will be taken off the study drug; and a treatment phase (up to 12 weeks) where you will be randomized to either study drug or placebo (inactive, sugar pill).
If interested, call (312) 563-2900 (press 4; give code name: PHOENIX)
You may be eligible to participate in this study if you:
- Are 18 years of age or older and able to walk at least 10 meters
- Have had a clinical diagnosis of symptomatic orthostatic hypotension associated with primary autonomic failure (PD, MSA, and PAF) or dopamine beta hydroxylase deficiency
- Are able to provide written informed consent
You will be excluded from the study if you:
- Are currently using vasoconstricting agents for the purpose of increasing blood pressure
- Have sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.