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Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension
Chelsea Therapeutics is currently recruiting patients for two pivotal phase III trials designed to demonstrate efficacy and support U.S. marketing approval of the orphan drug droxidopa in symptomatic Neurogenic Orthostatic Hypotension (NOH). This double-blind, placebo-controlled study will measure the efficacy of droxidopa on symptoms of orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, Pure Autonomic Failure), dopamine beta hydroxylane deficiency and non-diabetic neuropathy. 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 is also an inclusion criteria. The study will be a maximum of 7 weeks.
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension
Purpose
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.
Eligibility
Ages eligible for study: 18 years and older
Genders eligible for study: both
Accepts healthy volunteers: no
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.
For Additional Information Visit:
http://www.nohstudy.com/
http://clinicaltrials.gov/ct2/show/NCT00633880
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