Trials / Unknown
UnknownNCT04171453
Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Viatris Korea · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, non-comparative, non-interventional, prospective, and multi-center PMS study to observe safety and effectiveness of Lyrica CR (82.5mg, 165mg, 330mg) in Korean subjects under the actual condition of use. PMS is an obligation to K-MFDS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lyrica CR (Pregabalin) | Lyrica CR 82.5mg, 165mg, or 330mg OD |
Timeline
- Start date
- 2020-02-03
- Primary completion
- 2022-07-14
- Completion
- 2022-07-14
- First posted
- 2019-11-21
- Last updated
- 2022-06-21
Locations
3 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04171453. Inclusion in this directory is not an endorsement.