EUCTR2013-005118-36-ES
Active, not recruiting
Phase 1
A clinical study of Patients with symptomatic neurogenic orthostatic HypOtENsion to assess sustaIned effects of droXidopa therapy - PHOENIX
Chelsea Therapeutics, Incorporated0 sites450 target enrollmentMay 22, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Chelsea Therapeutics, Incorporated
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 18 years or older and ambulatory (defined as able to walk at least 10 meters)
- •2\. Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA, and PAF) or Dopamine Beta Hydroxylase Deficiency
- •3\. At the Baseline visit (Visit 2\), patients must demonstrate:
- •a. a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item \#1
- •b. a fall of at least 20 mmHg in their SBP, within 3 minutes of standing
- •4\. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 27
Exclusion Criteria
- •1\. Score of 23 or lower on the mini\-mental state examination (MMSE)
- •2\. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;
- •a. Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half\-lives (whichever is longer) prior to their baseline visit (Visit 2\) and throughout the duration of the study
- •3\. Known or suspected alcohol or substance abuse within the past 12 months
- •4\. Women who are pregnant or breastfeeding
- •5\. Women of childbearing potential (WOCP) who are not using at least one method of contraception with their partner
- •6\. Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic, or have these measurements at their Baseline Visit (Visit 2\). Sustained is defined as measurements persistently greater at 2 separate measurements at least 10 minutes apart with the subject supine and at rest for at least 5 minutes
- •7\. Untreated closed angle glaucoma
- •8\. Diagnosis of hypertension that requires treatment with antihypertensive medications (short\-acting antihypertensives to treat nocturnal supine hypertension are allowed in this study)
- •9\. Any significant uncontrolled cardiac arrhythmia
Outcomes
Primary Outcomes
Not specified
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