CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 389 enrolled
Drug / intervention
Atomoxetine +24 moredrug
Likely dose
Atomoxetine 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00223691
NCT00223691Phase 1Completed

Evaluation and Treatment of Autonomic Failure.

Vanderbilt University·interventional·Posted Sep 22, 2005·Updated Jan 18, 2017

In Brief

A Phase 1 clinical trial evaluating Atomoxetine, Acarbose, and 23 other interventions for Autonomic Failure and Orthostatic Hypotension. Completed, enrolled 389 participants across 1 site.

Detailed Summary

The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartMar 1, 2002
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 14.8 yearsPosted 20.8 years ago

Interventions

Atomoxetinedrug

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

Acarbosedrug

25-100 mg, PO. Single dose.

Pyridostigmine Bromidedrug

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

Yohimbinedrug

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

Midodrine HCldrug

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

placebodrug

PO.Single dose.

Modafinildrug

50-400 mg PO. Single dose

Octreotidedrug

5-50 µg, S.C. Single dose.

water intakeother

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

Diphenhydramine Hydrochloridedrug

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

Ranitidine HCLdrug

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

Tranylcyprominedrug

5 - 40 mg PO. Single dose

Ergotamine/ Caffeinedrug

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

Celecoxibdrug

50-200 mg PO. Single dose

Pseudoephedrinedrug

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

Methylphenidatedrug

5 or 10 mg PO. Single dose.

Indomethacindrug

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

Ibuprofendrug

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

Oxymetazoline 0.05% nasal solutiondrug

1-2 sprays/ nostril. Single dose.

Bovrildietary

6-10 g, PO. Single dose.

Acetazolamidedrug

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

Rivastigmine tartratedrug

1.5-6 mg PO. Single dose.

Carbidopa/levodopadrug

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

Inflatable abdominal binderdevice

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

inflatable abdominal binder (sham)device

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