Trial | NCT04128137  Report issue

Title

Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension
Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    90
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 (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.
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 patient will be followed for a maximum of 5 months, with no more than 8 visits to the investigator (V0 at Day-7, V1 at D0, V2 at D7, V3 at D+14, V4 at D+21, V5 at D+ 28, V6 at D+56 and V7 only for patients on the FLU arm at D+140.

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.
Study Started
Jul 09
2020
Primary Completion
Jun 30
2024
Anticipated
Study Completion
Jun 30
2024
Anticipated
Last Update
Oct 02
2023

Drug 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

  • Other names: Flucortac

Other 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

fludrocortisone Experimental

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.

Placebo Placebo Comparator

placebo of flucortac and same diagram of administration

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted