Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (NCT00738062) | Clinical Trial Compass
CompletedPhase 3
Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
United States103 participantsStarted 2008-01
Plain-language summary
The purpose of this study is to assess the durability of effect of Droxidopa in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
To be eligible for inclusion, each patient must fulfill the following criteria:
* Participated in Droxidopa Protocol 302;
* Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
Exclusion Criteria:
Patients are not eligible for this study if they fulfill one or more of the following criteria:
* Currently taking ephedrine or midodrine;
* Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days prior to their study entry visit (Visit 1).
* Currently taking anti-hypertensive medication;
\* The use of short-acting anti-hypertensive medications at bedtime is permitted.
* Currently taking tri-cyclic antidepressant medication or other norepinephrine re-uptake inhibitors;
* Have changed dose, frequency and or type of prescribed medication, within two weeks of study start (excluding ephedrine and midodrine);
* History of more than moderate alcohol consumption;
* History of known or suspected drug or substance abuse;
* Women of childbearing potential who are not using a medically accepted contraception;
* Reproductive potential:
* Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception.
* Acceptable contraceptives include intrauterine devic…
What they're measuring
1
Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)