Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403494
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2006-11-21
Brief Title:
A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
Sponsor:
BioMarin Pharmaceutical
Organization:
BioMarin Pharmaceutical
Study Overview
Official Title:
A Phase 2 Multicenter Multinational Randomized Double-blind Placebo-controlled Parallel Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
Status:
COMPLETED
Status Verified Date:
2020-12
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:
The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication IC caused by peripheral arterial disease PAD
Detailed Description:
This was a Phase 2 multicenter multinational prospective randomized double-blind placebo-controlled parallel study designed to assess the efficacy and safety of sapropterin dihydrochloride in subjects with intermittent claudication IC caused by peripheral arterial disease PAD Subjects who met initial screening criteria were monitored criteria and that dosages of permitted concomitant medications were stable
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