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Alpha Blocker
Alpha Blockade for Pheochromocytoma
Phase 3
Waitlist Available
Led By Michael Yeh, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of surgery (-2 to 3 weeks, -1 day, 30 days, 3 months, 6 months, 1 year)
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Summary
This trial compares two medications, phenoxybenzamine and doxazosin, to see which is better at controlling blood pressure in patients with a rare tumor called pheochromocytoma. These medications help keep blood vessels relaxed to prevent dangerous blood pressure spikes during surgery.
Eligible Conditions
- Pheochromocytoma
- Adrenal Gland Pheochromocytoma
- Paraganglioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of surgery (-2 to 3 weeks, -1 day, 30 days, 3 months, 6 months, 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of surgery (-2 to 3 weeks, -1 day, 30 days, 3 months, 6 months, 1 year)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemodynamic Instability
Secondary study objectives
Morbidity as Assessed by Occurrence of Adverse Events
Mortality
Quality of Life- Physical Functioning, Role Limitations Due to Physical Problems, Bodily Pain, General Health Perceptions, Vitality, Social Functioning, Role-limitations Due to Emotional Problems, and Mental Health
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DoxazosinExperimental Treatment1 Intervention
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Group II: PhenoxybenzamineActive Control1 Intervention
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxazosin
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,266,961 Total Patients Enrolled
Michael Yeh, MDPrincipal Investigator - University of California, Los Angeles
Resnick Neuropsychiatric Hospital at UCLA, Ronald Reagan UCLA Medical Center, Santa Monica-UCLA Medical Center
St George'S University (Medical School)
Ucla School Of Medicine (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Phenoxybenzamine
- Group 2: Doxazosin
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.