Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

H.A.C. Pharma

Status and phase: Enrolling; Phase 4

Conditions: Neurogenic Orthostatic Hypotension

Treatments: Drug: Fludrocortisone; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04128137

2018-003905-25

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

fludrocortisone

Experimental group

Description:

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.

Treatment:

Drug: Fludrocortisone

Placebo

Placebo Comparator group

Description:

placebo of flucortac and same diagram of administration

Treatment:

Other: Placebo