Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046475
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2002-09-30
Brief Title:
A Study for Patients With Neurogenic Orthostatic Hypotension
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Multi-Center Double-Blind Randomized Placebo-Controlled Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Patients With Neurogenic Orthostatic Hypotension
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are seeking male and female patients to voluntarily take part in a clinical research study Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension low blood pressure while in the upright position due to Parkinsons disease multiple system atrophy pure autonomic failure or autonomic neuropathies ie neurogenic orthostatic hypotension Symptoms of low blood pressure include dizziness lightheadedness changes in vision and generalized weakness upon standing The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease
The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride ProAmatine an approved treatment for orthostatic hypotension During the course of the study participants will receive either ProAmatine or a placebo Assessments will be made using questionnaires that measure symptom and activity levels Blood pressure in the lying down and standing positions will be measured at each visit
The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride ProAmatine an approved treatment for orthostatic hypotension During the course of the study participants will receive either ProAmatine or a placebo Assessments will be made using questionnaires that measure symptom and activity levels Blood pressure in the lying down and standing positions will be measured at each visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None