Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
Droxidopa NOH303
Universal Trial Number (UTN)
Trial acronym
NOH303
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurogenic Orthostatic Hypotension 0 0
Non-Diabetic Autonomic Neuropathy 0 0
Multiple System Atrophy 0 0
Dopamine Beta Hydroxylase Deficiency 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Change in Orthostatic Hypotension Daily Activities (OHDAS) Score
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
Patient Reported Clinical Global Impression - Severity
Timepoint [4] 0 0
14 days
Secondary outcome [5] 0 0
Clinician Recorded Clinical Global Impression - Severity
Timepoint [5] 0 0
14 days
Secondary outcome [6] 0 0
Patient Reported Clinical Global Impression - Improvement
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
Clinician Rated Clinical Global Impressions - Improvement
Timepoint [7] 0 0
14 days

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Baker Heart Research Institute - Melbourne
Recruitment hospital [3] 0 0
Austin Hospital - Heidelburg
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Heidelburg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
New Zealand
State/province [26] 0 0
Private Bag
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chelsea Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Horacio Kaufmann Kaufmann, MD
Address 0 0
NYU School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00738062