General Information
Zydus NASH SARO.16.005
A Phase 2, Prospective, Multicenter, Double-blind. Randomized Study of Saroglitazar Magnesium 1 mg, 2 mg or 4 mg versus Placebo in Patients with Nonalcoholic Fatty Liver Disease and/or Nobalcoholic Steatohepatitis
| Protocol | SARO.16.005 |
|---|---|
| Identifier | |
| UID | 6350e80a-473a-4e36-9871-c27aee8a48ae |
| Status | Done - Archived |
| Phase | 2 |
| Category | NASH / Adult |
| Launch Year | 2018 |
| NCT Number | - |
| Created | 2018-05-03 09:53 |
| Last Updated | 2018-05-03 09:53 |
Description
No description provided.
Comment
CRI
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 2019-04-13 | No |
| Enrollment Open | 2018-06-21 | No |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2018-06-13 | No |
| PI Meeting Start | No | |
| PI Meeting End | No | |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 2019-09-19 | No |
| Final PatientVisit | No | |
| PreStudy Selection Visit | No | |
| Target Date 12 | No | |
| Target Date 13 | No | |
| Target Date 14 | No |
Leadership
| Role | Staff | Login | Required |
|---|---|---|---|
| Principal | Mohseni, Rizwana | RMohseni | No |
| Recruiter | - | No | |
| Coordinator | Valenzuela, Louisito | LValenzuela | No |
| Regulatory | Perez, Myrna | MPerez | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Zydus Discovery DMCC |
|---|---|
| Division | Zydus Healthcare |
| Team | Zydus Healthcare |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | |
|---|---|
| CRO | Parexel International |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
