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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludrocortisone | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic BP diminution | Systolic BP diminution when moving from supine to standing, measured with a semi-automatic blood pressure monitor - AP in upright position: the lowest value of the measurements obtained every minute, for 5 minutes after rising. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine DENICOURT | Contact | 02 31 47 92 46 | catherine.denicourt@hacpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel SENARD, MD | National Coordinator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Broca (AP-HP) | Recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D005438 | Fludrocortisone |
| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
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|
| Placebo | Other | 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 |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |