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Alpha-1 Adrenergic Blocker
Doxazosin XL for Post-Traumatic Stress Disorder
Phase 4
Waitlist Available
Led By Anne Richards, MD, MPH
Research Sponsored by San Francisco Veterans Affairs Medical Center
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 up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This study will assess the effects of the medication doxazosin on sleep in men and women with PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist actigraphy.
Eligible Conditions
- Post-Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2013 Phase 4 trial • 395 Patients • NCT016616215%
Dry mouth
4%
Blurred vision
3%
Dry eye
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2
Group 1
Awards & Highlights
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.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Doxazosin XLExperimental Treatment1 Intervention
Subjects will participate in a 2 week flexible-dose titration of doxazosin XL based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
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?
San Francisco Veterans Affairs Medical CenterLead Sponsor
51 Previous Clinical Trials
211,244 Total Patients Enrolled
United States Department of DefenseFED
904 Previous Clinical Trials
333,214 Total Patients Enrolled
Northern California Institute of Research and EducationOTHER
29 Previous Clinical Trials
10,357 Total Patients Enrolled
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