General Information
Kowa K-877-303
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study with a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels >500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
| Protocol | K-877-303 |
|---|---|
| Identifier | |
| UID | 3d860235-9ba9-424e-9a7f-e309d5937037 |
| Status | Done - Archived |
| Phase | 3 |
| Category | High Cholesterol / Adult |
| Launch Year | 2016 |
| NCT Number | - |
| Created | 2016-10-26 18:12 |
| Last Updated | 2016-10-26 18:12 |
Description
No description provided.
Comment
PCRS
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | No | |
| Enrollment Open | 2017-01-03 | No |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2016-12-16 | No |
| PI Meeting Start | 2016-12-01 | No |
| PI Meeting End | 2016-12-02 | No |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 2018-07-25 | 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 | Martinez, Gilbert | GJMartinez | No |
| Recruiter | Miss, Salomon | SMiss | No |
| Coordinator | Cervantes, Edgar | ECervantes | No |
| Regulatory | Perez, Myrna | MPerez | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Kowa Research Institute, Inc. |
|---|---|
| Division | Kowa Research Institute |
| Team | Kowa Research Institute |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | |
|---|---|
| CRO | Medpace, Inc. |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
