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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/NCT00738062
Registration number
NCT00738062
Ethics application status
Date submitted
19/08/2008
Date registered
20/08/2008
Date last updated
16/05/2014
Titles & IDs
Public title
Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
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Scientific title
An Open-label Study, to Assess the Long-term Safety and Clinical Benefit of Droxidopa in Subjects With PAF, Dopamine Beta Hydroxylase Deficiency or Non-diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension
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Secondary ID [1]
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Droxidopa NOH303
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Universal Trial Number (UTN)
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Trial acronym
NOH303
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurogenic Orthostatic Hypotension
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Non-Diabetic Autonomic Neuropathy
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Multiple System Atrophy
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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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Neurological
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Neurodegenerative diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Droxidopa
Treatment: Drugs - Placebo
Active Comparator: Droxidopa - Study medication
Placebo Comparator: Placebo - Placebo
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
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
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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 Orthostatic Hypotension Questionnaire Composite Score (OHQ)
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Assessment method [1]
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The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-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. The OHDAS sub-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 item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization.
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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 Orthostatic Hypotension Daily Activities (OHDAS) Score
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Assessment method [1]
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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 randomization 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 Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score
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Assessment method [2]
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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 randomization 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 Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing
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Assessment method [3]
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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). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.
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Timepoint [3]
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14 days
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Secondary outcome [4]
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Patient Reported Clinical Global Impression - Severity
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Assessment method [4]
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The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;
Normal-Borderline OH (CGI-S 1-2),
Mild-Moderate OH (CGI-S 3-4),
Marked OH-Most Ill with OH (CGI-S 5-7). .
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Timepoint [4]
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14 days
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Secondary outcome [5]
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Clinician Recorded Clinical Global Impression - Severity
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Assessment method [5]
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The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;
Normal-Borderline OH (CGI-S 1-2),
Mild-Moderate OH (CGI-S 3-4),
Marked OH-Most Ill with OH (CGI-S 5-7).
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Timepoint [5]
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14 days
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Secondary outcome [6]
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Patient Reported Clinical Global Impression - Improvement
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Assessment method [6]
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The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.
Patients will be grouped according change in disease as follows;
Very Much Improved to Slightly Improved (CGI-I 1-3),
No Change (CGI-I 4),
Slightly Worse to Very Much Worse (CGI-I 5-7).
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Timepoint [6]
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14 days
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Secondary outcome [7]
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Clinician Rated Clinical Global Impressions - Improvement
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Assessment method [7]
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The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.
Patients will be grouped according change in disease as follows;
Very Much Improved to Slightly Improved (CGI-I 1-3),
No Change (CGI-I 4),
Slightly Worse to Very Much Worse (CGI-I 5-7).
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Timepoint [7]
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14 days
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Eligibility
Key inclusion criteria
To be eligible for inclusion, each patient must fulfill the following criteria:
- Participated in Droxidopa Protocol 302;
- 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.
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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
Patients are not eligible for this study if they fulfill one or more of the following
criteria:
- Currently taking ephedrine or midodrine;
- Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days
prior to their study entry visit (Visit 1).
- Currently taking anti-hypertensive medication;
* The use of short-acting anti-hypertensive medications at bedtime is permitted.
- Currently taking tri-cyclic antidepressant medication or other norepinephrine
re-uptake inhibitors;
- Have changed dose, frequency and or type of prescribed medication, within two weeks of
study start (excluding ephedrine and midodrine);
- History of more than moderate alcohol consumption;
- History of known or suspected drug or substance abuse;
- Women of childbearing potential who are not using a medically accepted contraception;
- Reproductive potential:
- Female subjects should be either post-menopausal (amenorrhea for at least 12
consecutive months), surgically sterile, or women of child-bearing potential
(WOCP) who are using or agree to use acceptable methods of contraception.
- Acceptable contraceptives include intrauterine devices (IUDs), hormonal
contraceptives (oral, depot, patch or injectable) and double barrier methods such
as condoms or diaphragms with spermicidal gel or foam.
- For WOCP a urine pregnancy test must be conducted at each study visit.
- WOCP must be advised to use acceptable contraceptives throughout the study period
and for 30 days after the last dose of investigational product.
- If hormonal contraceptives are used they should be taken according to the package
insert.
- WOCP who are not currently sexually active must agree to use acceptable
contraception, as defined above, if they decide to become sexually active during
the period of the study and for 30 days after the last dose of investigational
product.
- Sexually active males whose partner is a WOCP and who do not agree to use condoms for
the duration of the study and for 30 days after the last dose;
- Women who are pregnant or breast feeding;
- Known or suspected hypersensitivity to the study medication or any of its ingredients;
- 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;
- Any other significant systemic, hepatic, cardiac or renal illness;
- Diabetes mellitus or insipidus;
- Have a history of closed angle glaucoma;
- Have a known or suspected malignancy;
- Have a serum creatinine level > 130 umol/L;
- Patients with 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;
- In the investigator's opinion, are unable to adequately co-operate because of
individual or family situation;
- In the investigator's opinion, are suffering from a mental disorder that interferes
with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major
depression, dementia;
- Are not able or willing to comply with the study requirements for the duration of the
study.
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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
1/12/2010
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Sample size
Target
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Accrual to date
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Final
103
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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
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United States of America
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Alabama
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Colorado
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Florida
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Illinois
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the durability of effect of Droxidopa 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/NCT00738062
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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 Kaufmann, MD
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Address
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NYU School of Medicine
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00738062
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