A study to look at the long-term effects of droxidopa treatment in patients who experience low blood pressure when changing their posture

Phase 1

• Conditions: Symptomatic neurogenic orthostatic hypotension; MedDRA version: 17.0Level: PTClassification code 10031127Term: Orthostatic hypotensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-005118-36-IT
• Lead Sponsor: Chelsea Therapeutics, Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-28
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
10. History of myocardial infarction, within the past 2 years
11. Current unstable angina
12. Congestive heart failure (NYHA Class 3 or 4)
13. Diabetic autonomic neuropathy
14. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ
15. Gastrointestinal condition that may affect the absorption of study drug (e.g., ulcerative colitis, gastric bypass)
16. Any major surgical procedure within 30 days prior to the Baseline visit (Visit 2)
17. Previously treated with droxidopa within 30 days prior to the Baseline visit (Visit 2)
18. Currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the Baseline visit (Visit 2)
19. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study
20. The Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified