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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00633880
Registration number
NCT00633880
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Date last updated
20/05/2014
Titles & IDs
Public title
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
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Scientific title
Phase III, Multi-Center, Study to Assess the Clinical Effect of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic NOH
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Secondary ID [1]
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Droxidopa NOH302
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Universal Trial Number (UTN)
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Trial acronym
NOH302
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Symptomatic Neurogenic Orthostatic Hypotension (NOH)
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Non-diabetic Neuropathy
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Primary Autonomic Failure
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Dopamine Beta Hydroxylase Deficiency
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Droxidopa
Experimental: Droxidopa - Double-blind
Placebo Comparator: Placebo - Double-blind
Treatment: Drugs: Placebo
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Treatment: Drugs: Droxidopa
100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
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Assessment method [1]
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OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [1]
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14 days
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Secondary outcome [1]
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Change in Fatigue (OHSA Item 4)
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Assessment method [1]
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OHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [1]
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14 days
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Secondary outcome [2]
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Change in Weakness (OHSA Item 3)
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Assessment method [2]
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OHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [2]
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14 days
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Secondary outcome [3]
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Change in Vision (OHSA Item 2)
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Assessment method [3]
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OHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [3]
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14 days
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Secondary outcome [4]
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Change in Concentration (OHSA Item 5)
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Assessment method [4]
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OHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [4]
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14 days
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Secondary outcome [5]
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Change in Head/Neck Discomfort (OHSA Item 6)
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Assessment method [5]
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OHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [5]
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14 days
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Secondary outcome [6]
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Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)
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Assessment method [6]
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The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [6]
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14 days
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Secondary outcome [7]
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Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)
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Assessment method [7]
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The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [7]
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14 days
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Secondary outcome [8]
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Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)
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Assessment method [8]
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OHSA composite scale (items 2-6) is the average of five OHSA items: 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [8]
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14 days
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Secondary outcome [9]
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Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing;
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Assessment method [9]
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Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
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Timepoint [9]
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14 days
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Eligibility
Key inclusion criteria
PATIENT INCLUSION CRITERIA:
- Male or female and aged 18 years or over;
- Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic
Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic
Autonomic Neuropathies;
- A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic
blood pressure of at least 10 mmHg, within 3 minutes after standing;
- Provide written informed consent to participate in the study and understand that they
may withdraw their consent at any time without prejudice to their future medical care.
MAIN PATIENT EXCLUSION CRITERIA:
- Taking ephedrine or midodrine; Patients taking ephedrine or midodrine may enroll after
a minimum 7 day washout period;
- Taking anti-hypertensive medication;
- Have a history of more than moderate alcohol consumption;
- Women who are pregnant or lactating;
- Have a history of closed angle glaucoma;
- Have pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting
position);
- Have atrial fibrillation or, in the investigator's opinion, have any other significant
cardiac arrhythmia;
- In the investigator's opinion, have any other significant systemic, hepatic, cardiac
or renal illness;
- Have diabetes mellitus or insipidus;
- Have a known or suspected malignancy;
- Have known gastrointestinal illness or other gastrointestinal disorder that may, in
the investigator's opinion, affect the absorption of study drug;
- In the investigator's opinion, have clinically significant abnormalities on clinical
examination or laboratory testing;
- Have a serum creatinine level > 130 µmol/L;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2009
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Sample size
Target
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Accrual to date
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Final
181
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Baker Heart Research Institute - Melbourne
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Recruitment hospital [3]
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Austin Hospital - Heidelburg
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3084 - Heidelburg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Maryland
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Massachusetts
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Michigan
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North Carolina
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Ohio
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Ontario
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Quebec
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New Zealand
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Chelsea Therapeutics
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Chiltern International Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to see whether droxidopa is effective in treating symptoms of
neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic
Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta
Hydroxylase deficiency.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00633880
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Horacio Kaufmann, MD
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Address
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NYU Langone Health
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00633880
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