Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046163
Status:
TERMINATED
Last Update Posted:
2021-06-29
First Post:
2002-09-20
Brief Title:
A Phase IV Study in Subjects With Neurogenic Orthostatic Hypotension
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase IV Multi-Center Double-Blind Parallel Group Randomized Placebo-Controlled Study to Assess the Clinical Benefit of Three Doses of Midodrine Hydrochloride ProAmatine in Subjects With Neurogenic Orthostatic Hypotension
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to poor enrollment
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 effect of high dose 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 sitting and standing positions will be measured Patients will also complete standing time assessments They will be asked to remain standing without moving until they feel sufficiently lightheaded or dizzy or feel faint so that they would feel more comfortable sitting down
The purpose of this clinical study is to further assess the clinical effect of high dose 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 sitting and standing positions will be measured Patients will also complete standing time assessments They will be asked to remain standing without moving until they feel sufficiently lightheaded or dizzy or feel faint so that they would feel more comfortable sitting down
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