A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa (NCT00782340) | Clinical Trial Compass
CompletedPhase 3
A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa
United States263 participantsStarted 2008-09
Plain-language summary
The purpose of this study is to see whether droxidopa is effective 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
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
To be eligible for inclusion, each patient must fulfill the following criteria:
* Male or female and aged 18 years or over
* Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathies
* A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing;
* 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:
* Currently taking ephedrine or midodrine
* Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days prior to their baseline visit (Visit 2).
* 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
* For WOCP a serum beta HCG pregnancy test must be conducted at screening, and a urine pregnancy test must be conducted at baseline and …
What they're measuring
1
Change in Orthostatic Hypotension Questionnaire Score (OHQ)