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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of surgery (-2 to 3 weeks, -1 day, 30 days, 3 months, 6 months, 1 year) for reporting.

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

Do I qualify?Apply below to find out