Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
NCT ID: NCT04128137
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2020-07-09
2024-06-30
Brief Summary
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Detailed Description
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The presence of a comparator control group with placebo permits to evaluate the efficacy and the tolerance of FLU independently of the natural evolution of the pathology, in patients benefiting from a non-drug or possibly medicated treatment (midodrine) but insufficient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fludrocortisone
FLUCORTAC® 50 μg (tablet breackable). One tablet during the first week. Then 2 tablets during the second week. Then 3 tablets during the third week and finally 4 tablets during the 4th week. Maximum of 200μg/day.
Fludrocortisone
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
Placebo
placebo of flucortac and same diagram of administration
Placebo
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
Interventions
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Fludrocortisone
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
Placebo
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient suffering from a neurological disease
* orthostatic neurogenic hypotension persistent and symptomatic despite non-drug measures
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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H.A.C. PHARMA
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Michel SENARD, MD
Role: PRINCIPAL_INVESTIGATOR
National Coordinator
Locations
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Hôpital Broca (AP-HP)
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-003905-25
Identifier Type: -
Identifier Source: org_study_id
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