Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension
Summary
The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.
Timeline
- Start
- 2004-09-08
- Primary completion
- 2005-03-21
- Completion
- 2005-03-21
Outcome
Mixed primary results
registry MEAN Midodrine HCl: 551.3 (Standard Deviation 115.63) seconds NCT00555880 ↗
registry MEAN Placebo: 461.0 (Standard Deviation 190.74) seconds NCT00555880 ↗
registry analysis (unspecified test); Midodrine HCl vs Placebo; p = 0.1460; Sign Statistic 3.0; Sign test NCT00555880 ↗
registry LEAST_SQUARES_MEAN Midodrine HCl: 552.4 (Standard Error 32.93) seconds NCT00555880 ↗
registry LEAST_SQUARES_MEAN Placebo: 460.0 (Standard Error 32.93) seconds NCT00555880 ↗
registry analysis (unspecified test); Midodrine HCl vs Placebo; p = 0.0296; Least squares mean 92.4; ANOVA NCT00555880 ↗
registry analysis (unspecified test); Midodrine HCl vs Placebo; p = 0.0342; Signed Rank Test NCT00555880 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midodrine | Small molecule | 10 mg | Oral |
| Subject | Midodrine | Small molecule | 30 mg | Oral |