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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00103597
Date of registration: 11/02/2005
Prospective Registration: No
Primary sponsor: Royal Brisbane and Women's Hospital
Public title: Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Scientific title: Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Date of first enrolment: January 2005
Target sample size: 50
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00103597
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Australia
Contacts
Name:     Kerrie Schoffer, MBBS
Address: 
Telephone:
Email:
Affiliation:  Movement Disorders Fellow
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients residing in Queensland Australia

- Age 40-95

- Parkinson's Disease or MSA diagnosed by a neurologist

- Symptoms of orthostatic hypotension, as defined by 2 validated questionnaires

Exclusion Criteria:

- Patients with acute cardiomyopathy or cardiac condition

- Patients unable to give consent

- Patients not stable on their Parkinsonian medications

- Patients with another cause for autonomic neuropathy



Age minimum: 40 Years
Age maximum: 95 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Orthostatic Hypotension
Parkinson's Disease
Multiple System Atrophy
Intervention(s)
Behavioral: Conservative Measures for Orthostatic Hypotension
Drug: Fludrocortisone
Drug: Domperidone
Primary Outcome(s)
Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing
Secondary Outcome(s)
Secondary ID(s)
2004/135
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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