drugset
drugset / Trial / NCT00223691

Treatment of Orthostatic Hypotension in Autonomic Failure

NCT00223691 ↗

Phase 1 Completed 389 enrolled Vanderbilt University
RandomizedCrossoverSingle-blind

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.

Timeline

Start
2002-03
Primary completion
2017-01
Completion
2017-01

Outcome

Mixed primary results

paper Our primary outcome was the change in standing diastolic BP 60 minutes after drug administration from baseline. PMID 20837887 ↗

paper Yohimbine significantly improved standing diastolic BP as compared with placebo (11±3 mm Hg [95% CI: 6 to 16 mm Hg]; P<0.001). PMID 20837887 ↗

paper On the contrary, pyridostigmine did not increase the standing diastolic BP (0.6±3 mm Hg [95% CI: -5 to 5 mm Hg]; P=0.823). PMID 20837887 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acarbose Unknown 25 mg —
Subject Acarbose Unknown 100 mg —
Subject Acetazolamide Small molecule 125 mg —
Subject Acetazolamide Small molecule 1000 mg —
Subject Atomoxetine Other / unclassified 10 mg —
Subject Atomoxetine Other / unclassified 50 mg —
Subject Caffeine Small molecule 100 mg Oral
Subject Carbidopa Unknown 25 mg —
Subject Carbidopa Unknown 175 mg —
Subject Carbidopa/levodopa Unknown 10 mg —
Subject Carbidopa/levodopa Unknown 25 mg —
Subject Carbidopa/levodopa Unknown 100 mg —
Subject Celecoxib Other / unclassified 50 mg —
Subject Celecoxib Other / unclassified 200 mg —
Subject Diphenhydramine Small molecule 12.5 mg —
Subject Diphenhydramine Small molecule 100 mg —
Subject Ibuprofen Small molecule 300 mg —
Subject Ibuprofen Small molecule 600 mg —
Subject Ibuprofen Small molecule 900 mg —
Subject Indomethacin Small molecule 25 mg —
Subject Indomethacin Small molecule 50 mg —
Subject Indomethacin Small molecule 75 mg —
Subject Methylphenidate Small molecule 5 mg —
Subject Methylphenidate Small molecule 10 mg —
Subject Midodrine Small molecule 2.5 mg —
Subject Midodrine Small molecule 5 mg —
Subject Midodrine Small molecule 7.5 mg —
Subject Midodrine Small molecule 10 mg —
Subject Modafinil Small molecule 50 mg —
Subject Modafinil Small molecule 400 mg —
Subject Octreotide Peptide 5 ug —
Subject Octreotide Peptide 50 ug —
Subject Oxymetazoline Other / unclassified — Intranasal
Subject Pseudoephedrine Small molecule 15 mg —
Subject Pseudoephedrine Small molecule 30 mg —
Subject Pseudoephedrine Small molecule 60 mg —
Subject Pyridostigmine Small molecule 30 mg —
Subject Pyridostigmine Small molecule 180 mg —
Subject Ranitidine Unknown 150 mg —
Subject Ranitidine Unknown 300 mg —
Subject Rivastigmine Small molecule 1.5 mg —
Subject Rivastigmine Small molecule 6 mg —
Subject Tranylcypromine Small molecule 5 mg —
Subject Tranylcypromine Small molecule 40 mg —
Subject Yohimbine Small molecule 2.7 mg —
Subject Yohimbine Small molecule 5.4 mg —
Subject Yohimbine Small molecule 10.8 mg —
Subject ergotamine Small molecule 1 mg Oral

Indications

autonomic nervous system disorder orthostatic hypotension