Evaluation of efficacy and tolerance of fludrocortisone (Flucortac) in the treatment of neurogenic orthostatic hypotensio
- Conditions
- eurogenic Orthostatic Hypotension (NOH)MedDRA version: 20.0Level: PTClassification code 10031127Term: Orthostatic hypotensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-003905-25-FR
- Lead Sponsor
- H.A.C. Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
- Age >18 years
- Orthostatic hypotension (blodo pressure decrease >20 and/or 10mmHg on systolic and diastolic values within 3 minutes after stand-up, and symptomatic according to the Orthostatic Hypotension Questionnaire OHQ: score different than 0 in at least 1 of the 6 items
- Patients suffering from a neurologic disease (Parkinson disease, multisystemic atrophy, Lewy bodies dementia, isolated progressive dysautonomia) or metabolic disease (diabetes, renal failure) known to be linked with an autonomous nervous system dysfunction and with NOH
- Persistant and symptomatic NOH despite the use of non-medicinal measures (lower limbs contention) and medicinal products (midodrine)
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
- Age <18 years
- Hypersensitivity to FLU or to one of its excipients
- Medical history of documented cardiac failure
- Medical history of left ventricular systolic dysfunction
- Non-compensated hypokalaemia
- Nocturnal or supine hypertension
- Pregnant or breastfeeding patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method