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| ID | Type | Description | Link |
|---|---|---|---|
| P01NS044233 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Then Pyridostigmine | Active Comparator | participants first receive placebo by mouth 3 times a day, for treatment day 1. Then participants receive pyridostigmine by mouth 3 times a day for treatment day 2. |
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| Pyridostigmine, Then Placebo | Active Comparator | participants first receive pyridostigmine by mouth 3 times a day, for treatment day 1. Then participants receive placebo by mouth 3 times a day for treatment day 2. |
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| Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine | Experimental | participants first receive placebo by mouth 3 times a day, for treatment day 3. Then participants receive Droxidopa by mouth 3 times a day for treatment day 4. |
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| Droxidopa and Pyridostigmine, Then Droxidopa and Placebo | Experimental | participants first receive Droxidopa by mouth 3 times a day, for treatment day 3. Then participants receive Placebo by mouth 3 times a day for treatment day 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droxidopa | Drug | 100 mg tablets by mouth three times a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in orthostatic diastolic blood pressure | diastolic blood pressure measured upon standing reported in mm/Hg | 1 hour after medication administration, 2 hours after medication administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in orthostatic systolic blood pressure | systolic blood pressure measured upon standing reported in mm/Hg | 1 hour after medication administration, 2 hours after medication administration |
| Change in absolute supine diastolic blood pressure |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Singer, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015103 | Droxidopa |
| D011729 | Pyridostigmine Bromide |
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Placebo-controlled, double-blind, randomized four-way crossover
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| Pyridostigmine | Drug | 60 mg tablets by mouth three times a day |
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| Placebo | Other | Looks exactly like the study drug but contains no active ingredients |
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diastolic blood pressure measured while lying flat reported in mm/Hg
| 1 hour after medication administration, 2 hours after medication administration |
| Change in absolute supine systolic blood pressure | systolic blood pressure measured while lying flat reported in mm/Hg | 1 hour after medication administration, 2 hours after medication administration |
| Change in supine norepinephrine levels | measure of serum norepinephrine levels while lying flat reported in pg/mL | 1 hour after medication administration, 2 hours after medication administration |
| Change in orthostatic symptoms | measured during tilt study, the patient will be asked to score orthostatic symptoms on a symptom scale ranging from "0" = no symptoms to "10" = near syncope | 1 hour after medication administration, 2 hours after medication administration |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |