Treatment of Orthostatic Hypotension in Autonomic Failure
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ClinicalTrials.gov Identifier: NCT00223691 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : January 18, 2017
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Condition or disease | Intervention/treatment | Phase |
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Autonomic Failure Orthostatic Hypotension | Drug: Atomoxetine Drug: Acarbose Drug: Pyridostigmine Bromide Drug: Yohimbine Drug: Midodrine HCl Drug: placebo Drug: Modafinil Drug: Octreotide Other: water intake Drug: Diphenhydramine Hydrochloride Drug: Ranitidine HCL Drug: Tranylcypromine Drug: Ergotamine/ Caffeine Drug: Celecoxib Drug: Pseudoephedrine Drug: Methylphenidate Drug: Indomethacin Drug: Ibuprofen Drug: Oxymetazoline 0.05% nasal solution Dietary Supplement: Bovril Drug: Acetazolamide Drug: Rivastigmine tartrate Drug: Carbidopa/levodopa Device: Inflatable abdominal binder Device: inflatable abdominal binder (sham) | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 389 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Official Title: | Evaluation and Treatment of Autonomic Failure. |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
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Experimental: 1: active intervention
atomoxetine, pyridostigmine bromide, yohimbine, midodrine hcl, modafinil, octreotide, water intake, ranitidine hcl, diphenhydramine hydrochloride, tranylcypromine, ergotamine/ caffeine, celecoxib, pseudoephedrine, methylphenidate, indomethacin, ibuprofen, Oxymetazoline 0.05% nasal solution, acarbose, Rivastigmine tartrate, acetazolamide, carbidopa/levodopa, inflatable abdominal binder or bovril
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Drug: Atomoxetine
10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.
Other Name: Strattera Drug: Acarbose 25-100 mg, PO. Single dose.
Other Name: Precose Drug: Pyridostigmine Bromide 30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.
Other Name: Mestinon Drug: Yohimbine 2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.
Other Name: Yocon Drug: Midodrine HCl 2.5, 5.0, 7.5, 10 mg PO. Single dose
Other Name: ProAmatine Drug: Modafinil 50-400 mg PO. Single dose
Other Name: Provigil Drug: Octreotide 5-50 µg, S.C. Single dose.
Other Name: Sandostatin 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
Other Name: Benadryl Drug: Ranitidine HCL 150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.
Other Name: zantac Drug: Tranylcypromine 5 - 40 mg PO. Single dose
Other Name: Parnate Drug: Ergotamine/ Caffeine Ergotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose
Other Name: Cafergot Drug: Celecoxib 50-200 mg PO. Single dose
Other Name: Celebrex Drug: Pseudoephedrine 15, 30 or 60 mg, PO. Single dose.
Other Name: Sudafed Drug: Methylphenidate 5 or 10 mg PO. Single dose.
Other Name: Ritalin Drug: Indomethacin 25, 50 or 75 mg, PO. Singe dose.
Other Name: Indocin Drug: Ibuprofen 300, 600 or 900 mg, PO. Single dose.
Other Name: Advil, Motrin Drug: Oxymetazoline 0.05% nasal solution 1-2 sprays/ nostril. Single dose.
Other Name: Afrin 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
Other Name: Diamox Drug: Rivastigmine tartrate 1.5-6 mg PO. Single dose.
Other Name: Exelon Drug: Carbidopa/levodopa 10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg
Other Name: Sinemet, Lodosyn 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).
Other Name: external abdominal compression |
Placebo Comparator: 2: Placebo or sham device
placebo pill or inflatable abdominal binder (sham)
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Drug: placebo
PO.Single dose. 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).
Other Name: external abdominal compression (sham) |
- Increase in seated systolic blood pressure 1-hr post drug compared to baseline. [ Time Frame: 1.5-4 hours ]
- Increase in standing time 1-hr post drug compared to baseline [ Time Frame: 1.5-4 hours ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients referred for evaluation of their autonomic function
- Ages 18-85
Exclusion Criteria:
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223691
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00223691 History of Changes |
Other Study ID Numbers: |
000814 HL46681 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
orthostatic hypotension autonomic failure |
Hypotension, Orthostatic Pure Autonomic Failure Hypotension Vascular Diseases Cardiovascular Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Acarbose Diphenhydramine Promethazine Ibuprofen Celecoxib Indomethacin |
Octreotide Phenylephrine Acetazolamide Pseudoephedrine Oxymetazoline Ephedrine Midodrine Ergotamine Bromides Levodopa Carbidopa Carbidopa, levodopa drug combination Tranylcypromine Caffeine Methylphenidate |