N/A
Completed N=3,932
Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
Source: ClinicalTrials.gov NCT00659607 ↗Enrolled (actual)
3,932
Serious AEs
0.0%
Results posted
Oct 2009
Primary outcomePrimary: Unexpected Adverse Events — 0.58 Percentage of patients
Summary
This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
2. Frequency of incidence and its change in adverse events (AEs)
3. Factors on the safety profile of the study drug
4. Factors on the efficacy profile of the study drug
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unexpected Adverse Events |
0.58 | — |
| PRIMARY Frequency of Adverse Events |
1.04 | — |
| PRIMARY Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 |
-29 | <0.0001 sig |
| PRIMARY Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 |
-15 | <0.0001 sig |
| PRIMARY Effective Rate |
99 | — |
| SECONDARY Gender Factors Affecting the Safety Profile |
1.24; 0.88 | 0.2669 |
| SECONDARY Age Factors Affecting the Safety Profile |
0; 1.32; 1.20; 1.13; 0.88; 1.04 | 0.9674 |
| SECONDARY Proportion of Geriatric Population Factor Affecting the Safety Profile |
1.03; 1.07 | 0.9207 |
| SECONDARY Treatment Type Factors Affecting the Safety Profile |
0; 1.10; 1.40 | 0.8249 |
| SECONDARY Medical History Factors Affecting the Safety Profile |
1.97; 0.68 | 0.0003 sig |
| SECONDARY Concomitant Disease Factors Affecting the Safety Profile |
2.30; 0.56 | <0.0001 sig |
| SECONDARY Medical History Factors Affecting the Efficacy Profile |
98.1; 99.2 | 0.0075 sig |
| SECONDARY Previous Medication Factors Affecting the Efficacy Profile |
98.3; 99.6 | 0.0007 sig |
| SECONDARY Baseline Severity of Hypertension Factors Affecting the Efficacy Profile |
98.3; 99.2; 98.3 | 0.0393 sig |
| SECONDARY Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile |
98.8; 95.8; 99.4 | 0.0245 sig |
Eligibility Criteria
Inclusion Criteria
patients diagnosed with essential hypertension
Exclusion Criteria
patients who took Micardis Plus before participating in this PMS study
Data sourced from ClinicalTrials.gov (NCT00659607). 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.