Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」

Study Overview
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Brief Summary
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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.

Detailed Description
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This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially available. The surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to ARB combination drugs, as well as changes in parameters such as blood pressure. The usual adult dosage of Candesartan cilexetil is 4 to 8 mg, administered orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.

Official Title
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Blopress Tablets Special Drug Use Surveillance 「Challenge - Quality Control」

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Candesartan Cilexetil


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candesartan Cilexetil tablets (2 to 12 mg)<br>Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months | Drug: Candesartan Cilexetil<br>* Candesartan Cilexetil tablet<br>* Other names: Blopress;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Clinic Blood Pressure in the Sitting Position | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported. | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | 
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported. | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | 
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) | 
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Baseline and Last dose of ARB Combination Drug (up to Month 6) | 
| 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 | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. | Baseline and Last dose of ARB Combination Drug (up to Month 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Up to Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy