Trials / Completed
CompletedNCT04781881
Special Drug Use Surveillance for Entresto Tablets
Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 688 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.
Detailed description
This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the RMP-specified additional pharmacovigilance activities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entresto | There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled. |
Timeline
- Start date
- 2021-03-04
- Primary completion
- 2023-04-21
- Completion
- 2023-04-21
- First posted
- 2021-03-04
- Last updated
- 2023-05-06
Locations
121 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04781881. Inclusion in this directory is not an endorsement.