Treatment of Orthostatic Hypotension in Autonomic Failure

PHASE1CompletedINTERVENTIONAL
Enrollment

389

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Autonomic FailureOrthostatic Hypotension
Interventions
DRUG

Atomoxetine

10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.

DRUG

Acarbose

25-100 mg, PO. Single dose.

DRUG

Pyridostigmine Bromide

30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.

DRUG

Yohimbine

2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.

DRUG

Midodrine HCl

2.5, 5.0, 7.5, 10 mg PO. Single dose

DRUG

placebo

PO.Single dose.

DRUG

Modafinil

50-400 mg PO. Single dose

DRUG

Octreotide

5-50 µg, S.C. Single dose.

OTHER

water intake

Tap water 2 onz., 8 oz., 16 oz. PO, alone or in combination with any of the above medications. Single dose.

DRUG

Diphenhydramine Hydrochloride

12.5 mg-100 mg PO. Single dose. Alone or in combination with Ranitidine

DRUG

Ranitidine HCL

150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.

DRUG

Tranylcypromine

5 - 40 mg PO. Single dose

DRUG

Ergotamine/ Caffeine

Ergotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose

DRUG

Celecoxib

50-200 mg PO. Single dose

DRUG

Pseudoephedrine

15, 30 or 60 mg, PO. Single dose.

DRUG

Methylphenidate

5 or 10 mg PO. Single dose.

DRUG

Indomethacin

25, 50 or 75 mg, PO. Singe dose.

DRUG

Ibuprofen

300, 600 or 900 mg, PO. Single dose.

DRUG

Oxymetazoline 0.05% nasal solution

1-2 sprays/ nostril. Single dose.

DIETARY_SUPPLEMENT

Bovril

6-10 g, PO. Single dose.

DRUG

Acetazolamide

125-1000 mg PO. Single dose. Alone or in combination with yohimbine or midodrine

DRUG

Rivastigmine tartrate

1.5-6 mg PO. Single dose.

DRUG

Carbidopa/levodopa

10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg

DEVICE

Inflatable abdominal binder

External abdominal compression (20-40 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).

DEVICE

inflatable abdominal binder (sham)

External abdominal compression (5 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).

Trial Locations (1)

37232

Vanderbilt University, Nashville

All Listed Sponsors
lead

Vanderbilt University

OTHER

NCT00223691 - Treatment of Orthostatic Hypotension in Autonomic Failure | Biotech Hunter | Biotech Hunter