Neurogenic Orthostatic Hypotension (NOH) MedDRA version: 20.0 Level: PT Classification code 10031127 Term: Orthostatic hypotension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Flucortac
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
H.A.C. Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the symptoms related to NOH through the OHQ scale Evaluation of the quality of life through the SF36 scale Collection of clinical adverse events, biological and blood pressure anomalies.;Timepoint(s) of evaluation of this end point: OHQ scale and safety endpoints at each scheduled visit SF36 scale at screening visit and at the end of the double blind period | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a 4-week treatment with fludrocortisone (FLU) at stable dose on the decrease of systolic and diastolic blood pressure after 5 minutes of active orthostatism, in patients with neurogenic orthostatic hypotension;Secondary Objective: - To evaluate the efficient dose of FLU to control NOH - To evaluate the effect of FLU on systolic blood pressure in supine and stand-up positions - To evaluate the effect of FLU on systolic blood pressure (BP) in supine and stand-up positions - To evaluate the effect of a treatment with FLU on prevalance and severity of the symptoms related to NOH - To evaluate the full responders rate (no symptoms and BP decrease <20 and/or 10 mmHg for systolic and diastolic values respectively) or partial responders rate (no symptoms but persistance of BP decrease) during treatment with FLU - To evaluate the effect of the treatment on nocturnal decubitus BP - To evaluate the effect of the treatment on left ventricular mass and ejection fraction on cardiac ultrasound - To evaluate the safety (adverse events) of FLU in the studied indication - To evaluate the effect of the treatment on the quality of life;Primary end point(s): Efficacy on the systolic and diastolic BP decrease when moving from supine and stand-up position;Timepoint(s) of evaluation of this end point: At each scheduled visit | — |
Countries
France
Contacts
Public ContactCatherine Denicourt
H.A.C. Pharma
Outcome results
None listed