N/A
Completed N=1,425
Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use
Source: ClinicalTrials.gov NCT01050062 ↗Enrolled (actual)
1,425
Serious AEs
2.6%
Results posted
Jan 2013
Primary outcomePrimary: Incidence of Adverse Events (AEs) — 221; 72; 293; 154 Patients
Summary
The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AEs) |
221; 72; 293; 154; 46; 200 | — |
| SECONDARY Systolic Blood Pressure (SBP) |
152.9; 155.4; 153.5; 132.2; 134.7; 132.8 | — |
| SECONDARY Diastolic Blood Pressure (DBP) |
84.7; 84.6; 84.7; 75.2; 75.5; 75.3 | — |
| SECONDARY Target Blood Pressure Achievement Rate |
52.9; 43.2; 50.5 | — |
| SECONDARY Blood Pressure Normalised Rate |
70.7; 61.1; 68.3 | — |
Eligibility Criteria
Inclusion criteria
Hypertensive patients who have never taken Micombi Tablets.
Exclusion criteria
None
Data sourced from ClinicalTrials.gov (NCT01050062). 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.