Status:
UNKNOWN
Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
Lead Sponsor:
H.A.C. PHARMA
Conditions:
Neurogenic Orthostatic Hypotension
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (H...
Detailed Description
The objective of the study is to demonstrate the efficacy of FLU on systolic blood pressure depression in patients with neurogenic orthostatic hypotension. The study is randomised versus placebo.Each ...
Eligibility Criteria
Inclusion
- Diagnosis of orthostatic hypotension (HO), ie a blood pressure drop\> 20 and / or 10 mmHg within 3 minutes after active and symptomatic lifting
- Patient suffering from a neurological disease
- orthostatic neurogenic hypotension persistent and symptomatic despite non-drug measures
Exclusion
- Hypersensitivity to FLU or any of its excipients
- non orthostatic neurogenic hypotension
- History of proven heart failure
- History of left ventricular systolic dysfunction
- Uncompensated hypokalemia
- Patient with poorly balanced Grade 3 hypertension
- Pregnant patient at the time of inclusion
- Nursing patient
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04128137
Start Date
July 9 2020
End Date
June 1 2024
Last Update
October 2 2023
Active Locations (1)
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1
Hôpital Broca (AP-HP)
Paris, France, 75010