N/A
Completed N=14,151
Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
Source: ClinicalTrials.gov NCT02166697 ↗Enrolled (actual)
14,151
Serious AEs
2.3%
Results posted
Jul 2016
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions (ADR) — 230 Participants
Summary
The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions (ADR) |
230 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) |
320 | — |
| SECONDARY Incidence of Cerebrovascular/Cardiovascular Events |
0.24; 0.57; 2.34; 0.15; 0.99; 0.27 | — |
| SECONDARY Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities |
0.21; 0.41; 1.55; 0.10; 0.62; 0.10 | — |
| SECONDARY Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities |
0.20; 0.53; 2.19; 0.13; 1.06; 0.33 | — |
| SECONDARY Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities |
0.35; 0.81; 3.48; 0.23; 1.28; 0.35 | — |
Eligibility Criteria
Inclusion Criteria: Hypertensive patients with at least one of the following risk factors:
- Waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female
- Fasting triglyceride level ≥ 150 milligram per deciliter (mg/dL)
- High-density lipoprotein (HDL) cholesterol level less than (<) 40 mg/dL
- Fasting blood glucose level ≥ 110 mg/dL
- Body-mass index (BMI) ≥ 25.0 * Patients currently taking medications for hypertriglyceridemia, hypo-HDL-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance
Exclusion Criteria: Hypertensive patients who meet all of the following conditions ([1] to [3]):
- Patients receiving continuous therapy with Blopress Tablets
- Patients aged < 20 years or ≥ 75 years
- Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance
Data sourced from ClinicalTrials.gov (NCT02166697). 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.