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Study has been terminated due to poor accrual.
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The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Minoxidil |
|
| 2 | Active Comparator | Hydralazine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil | Drug | 2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Change in Blood Pressure | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Maitland, M.D., Ph.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydralazine | 25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week |
| FG001 | Minoxidil | 2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydralazine | 25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week |
| BG001 | Minoxidil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Magnitude of Change in Blood Pressure | No participants analyzed due to poor accrual and insufficient numbers of participants. | Posted | 21 days |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydralazine | 25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea (grade 1) | Gastrointestinal disorders | Systematic Assessment |
This study enrolled only 2 subjects and due to poor accrual, enrollment was stopped early. Due to the limited number of subjects available results cannot be assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Maitland, MD, PhD | University of Chicago | 773-702-4400 | mmaitlan@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D006830 | Hydralazine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Hydralazine | Drug | 25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week |
|
2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Minoxidil | 2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week | 0 | 2 | 1 | 2 |
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| D010793 |
| Phthalazines |
| D011724 | Pyridazines |