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Clinical Trials/NCT00889135
NCT00889135Approved For MarketingNot Applicable

Long Term Treatment With L-DOPS

Vanderbilt University1 site in 1 countryStarted: September 2004Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Approved For Marketing
Locations
1
Study OverviewEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18 years old or older with orthostatic hypotension
  • •established diagnosis of DBH deficiency and fractionated plasma catecholamine levels that show high dopamine levels and very low norepinephrine and epinephrine levels. Blood pressure increase in response to oral treatment with L-DOPS during previous studies.

Exclusion Criteria

  • •subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Robertson

Professor of Medicine and Pharmacology

Vanderbilt University

Study Sites (1)

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