N/A
Completed N=18,113
Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」
Source: ClinicalTrials.gov NCT02211638 ↗Enrolled (actual)
18,113
Serious AEs
0.2%
Results posted
Nov 2018
Primary outcomePrimary: Changes in Clinic Blood Pressure in the Sitting Position — -20.1; -18.1; -10.4; -9.3 mmHg
Summary
The purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Clinic Blood Pressure in the Sitting Position |
-20.1; -18.1; -10.4; -9.3 | — |
| PRIMARY Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 |
-19.8; -19.5; -10.1; -10.0 | — |
| PRIMARY Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 |
-21.7; -12.3; -26.4; -11.8; -6.4; -14.4 | — |
| PRIMARY Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 |
-24.5; -13.2 | — |
| PRIMARY Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14 |
-26.9; -14.7 | — |
| SECONDARY Number of Participants Who Experience at Least One Adverse Drug Reactions |
132 | — |
Eligibility Criteria
Inclusion Criteria
- Hypertensive patients
Exclusion Criteria
- Inpatients
- Patients under dialysis (planned)
- Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months
- Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure
- Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past
- Patients who are pregnant or may possibly become pregnant
Data sourced from ClinicalTrials.gov (NCT02211638). 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.