Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02634151
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2015-12-11
Brief Title:
A 12-Week Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
Sponsor:
NeuroBo Pharmaceuticals Inc
Organization:
NeuroBo Pharmaceuticals Inc
Study Overview
Official Title:
A 12-Week Phase 2 Randomized Placebo-Controlled Double-Blind Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy
Status:
COMPLETED
Status Verified Date:
2020-06
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:
ROYAL-1
Brief Summary:
The purpose of this study was to assess the efficacy safety and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy Patients with HeFH ASCVD or otherwise uncontrolled may be included with baseline LDL-C value 100 mgdL Subjects were randomized 11 to gemcabene 600 mg once daily QD or placebo
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