N/A
Completed N=20,994
J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
Source: ClinicalTrials.gov NCT00659581 ↗Enrolled (actual)
20,994
Serious AEs
5.2%
Results posted
Mar 2012
Primary outcomePrimary: Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events — 479; 19964 Number of participants
Summary
The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following:
1. Adverse events and adverse drug reactions under long-term use
2. Blood pressure measurements during the survey period
3. Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
4. Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events |
479; 19964 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at 6 Months |
-20.6 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at 6 Months |
-10.3 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at 12 Months |
-22.2 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at 12 Months |
-11.3 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at 24 Months |
-23.9 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at 24 Months |
-12.3 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at 36 Months |
-25.0 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at 36 Months |
-13.1 | — |
Eligibility Criteria
Inclusion criteria
Hypertension patients unadministered Micardis.
Exclusion criteria
- Patients with a history of hypersensitivity to any ingredient of this product.
- Pregnant woman or possibly pregnant woman
- Patients with extremely poor bile secretion or patients with serious hepatic disorder
Data sourced from ClinicalTrials.gov (NCT00659581). 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.