Overview
Sponsor-declared trial summary
Neurogenic Orthostatic Hypotension
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
Key facts
- Sponsor
- H.A.C. Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 9 Jul 2020 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517841-16-00
- EudraCT number
- 2018-003905-25
- ClinicalTrials.gov
- NCT04128137
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
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 objectives 8
- 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 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
Conditions and MedDRA coding
Neurogenic Orthostatic Hypotension
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age >18 years
- Orthostatic hypotension (blodo pressure decrease >20 and/or 10mmHg on systolic and diastolic values within 3 minutes after standup, 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)
Exclusion criteria 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Efficacy on the systolic and diastolic BP decrease when moving from supine and stand-up position
Secondary endpoints 3
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
FLUCORTAC 50 microgrammes, comprimé sécable
PRD2072822 · Product
- Active substance
- Fludrocortisone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 µg microgram(s)
- Max total dose
- 36000 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AA02 — FLUDROCORTISONE
- Marketing authorisation
- 3400939060668
- MA holder
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS - AP-HP
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Cellulose microcristalline 50 microgrammes
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H.A.C. Pharma
- Sponsor organisation
- H.A.C. Pharma
- Address
- Pericentre 2, 43 Avenue De La Cote De Nacre 43 Avenue De La Cote De Nacre
- City
- Caen
- Postcode
- 14000
- Country
- France
Scientific contact point
- Organisation
- H.A.C. Pharma
- Contact name
- CERFON
Public contact point
- Organisation
- H.A.C. Pharma
- Contact name
- CERFON
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 90 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2020-07-09 | 2024-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2024-517841-16-00_PROTOCOLE_FLU-HON | 3 |
| Recruitment arrangements (for publication) | 2024-517841-16-00_Recruitment arrangements_FLU-HON | 1 |
| Subject information and informed consent form (for publication) | 2024-517841-16-00_NICE_FLU-HON | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-517841-16-00_RCP Flucortac_FLU-HON | 1 |
| Synopsis of the protocol (for publication) | 2024-517841-16-00_SYNOPSIS_FLU-HON | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-01 | France | Acceptable 2024-10-25
|
2024-10-29 |