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Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday activities in hemodialysis patients. Since information regarding the use of droxidopa in clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Droxidopa, antihypotensive drug, tablet | Experimental |
| |
| placebo, tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droxidopa | Drug | 200mg/tab 2tablets, po, three times a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean ΔSBP after hemodialysis | ΔSBP = supine SBP (right before standing up) - nadir standing SBP | from Week 0 (visit 1-3) to Week 4 (visit 13-15) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event,Serious adverse event | from week 0 to week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai-Szu Wu | Taipei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan |
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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 |
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
200mg/tab, po, three times a week. |
|
| 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 |