N/A
Completed N=3,317
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Source: ClinicalTrials.gov NCT00749775 ↗Enrolled (actual)
3,317
Serious AEs
0.5%
Results posted
Jan 2014
Primary outcomePrimary: Number of Participants With Treatment Related Adverse Events. — 75 participants
Summary
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Related Adverse Events. |
75 | — |
| PRIMARY Number of Participants With Serious Treatment Related Adverse Events. |
16 | — |
| SECONDARY Change in Systolic Blood Pressure Over Time. |
151.8; 140.7; 137.5; 134.7; 134.0 | <0.001 sig |
| SECONDARY Change in Diastolic Blood Pressure Over Time. |
85.1; 79.5; 78.0; 76.6; 77.0 | <0.001 sig |
| SECONDARY Number of Participants That Responded to Selara Treatment. |
2772 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female patients who are prescribed Selara tablet for Hypertension.
Exclusion Criteria
- Subjects who have been prescribed Selara tablet.
Data sourced from ClinicalTrials.gov (NCT00749775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.