Overview

Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chelsea Therapeutics
Collaborator:
Chiltern International Inc.
Treatments:
Dopamine
Dopamine Agents
Droxidopa
Criteria
PATIENT INCLUSION 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.

MAIN PATIENT EXCLUSION CRITERIA:

- Taking ephedrine or midodrine; Patients taking ephedrine or midodrine may enroll after
a minimum 7 day washout period;

- Taking anti-hypertensive medication;

- Have a history of more than moderate alcohol consumption;

- Women who are pregnant or lactating;

- Have a history of closed angle glaucoma;

- Have pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting
position);

- Have atrial fibrillation or, in the investigator's opinion, have any other significant
cardiac arrhythmia;

- In the investigator's opinion, have any other significant systemic, hepatic, cardiac
or renal illness;

- Have diabetes mellitus or insipidus;

- Have a known or suspected malignancy;

- Have known gastrointestinal illness or other gastrointestinal disorder that may, in
the investigator's opinion, affect the absorption of study drug;

- In the investigator's opinion, have clinically significant abnormalities on clinical
examination or laboratory testing;

- Have a serum creatinine level > 130 µmol/L;