Shy-Drager SyndromeNCT00004478
Droxidopa in Treating Patients With Neurogenic Hypotension
A study testing droxidopa in people with Shy-Drager Syndrome and Orthostatic Hypotension, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880. RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. It causes one to feel dizzy, light headed, and weak. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Shy-Drager Syndrome, Orthostatic Hypotension
- What is being tested?
- droxidopa
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Mar 2006
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Orthostatic hypotension due to autonomic nervous system failure Fall in systolic blood pressure (supine to standing) of at least 20 mm Hg and diastolic blood pressure of at least 15 mm Hg AND Symptoms of hypotension such as dizziness, light-headedness, unsteadiness, dimming or blurred vision
- History of syncope or near-syncope
--Prior/Concurrent Therapy--
- Endocrine therapy: No concurrent adrenergics Concurrent fludrocortisone allowed
- Other: Concurrent indomethacin, support garments, and high salt diets allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Study of Droxidopa in Patients With Neurologic Hypotension
Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880.
RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. It causes one to feel dizzy, light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension.
PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.
Read the detailed description
PROTOCOL OUTLINE:
Patients receive escalating doses of droxidopa or placebo for 7-14 days. Patients undergo blood pressure measurements hourly in both supine and standing positions.
- Conditions
- Shy-Drager Syndrome, Orthostatic Hypotension
- Being tested
- droxidopa
- Keywords
- Shy-Drager Syndrome, cardiovascular and respiratory diseases, neurologic and psychiatric disorders, orthostatic hypotension, rare disease
- Medical subject headings
- Shy-Drager Syndrome, Hypotension, Orthostatic, Respiratory Tract Diseases, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
droxidopaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMar 1999
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shy-Drager SyndromeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Horacio Kaufmann, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004478
- Sponsor's protocol ID
- 199/14180
- Other IDs
- MTS-GCO-98-243-3-NE
- Status last verified
- Sep 2008
- First submitted
- 18 Oct 1999
- Last updated
- 18 Sep 2008
- Results posted
- No
Publications
Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003 Aug 12;108(6):724-8. doi: 10.1161/01.CIR.0000083721.49847.D7. Epub 2003 Jul 28.
PubMed 12885750Goldstein DS, Holmes C, Kaufmann H, Freeman R. Clinical pharmacokinetics of the norepinephrine precursor L-threo-DOPS in primary chronic autonomic failure. Clin Auton Res. 2004 Dec;14(6):363-8. doi: 10.1007/s10286-004-0221-z.
PubMed 15666063