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

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan Cilexetil

• Registration Number: NCT02211638
• Lead Sponsor: Takeda

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06-13
• Primary Completion: 2013-04-25
• Study Completion: 2013-04-25
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Results First Submitted: 2017-09-01
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-09
• Last Update Submitted: 2018-04-09
• Results First Posted: 2018-11-05
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18113

Inclusion Criteria

• Hypertensive patients

Exclusion Criteria

1. Inpatients
2. Patients under dialysis (planned)
3. Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months
4. Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure
5. Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past
6. Patients who are pregnant or may possibly become pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Candesartan Cilexetil tablets (2 to 12 mg)	Candesartan Cilexetil	Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months

Primary Outcome Measures

Name	Time	Method
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14	Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6)	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.
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14	Baseline and Last dose of ARB Combination Drug (up to Month 6)	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.
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	Baseline and Last dose of ARB Combination Drug (up to Month 6)	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.
Changes in Clinic Blood Pressure in the Sitting Position	Baseline, Month 3 and Last dose of Candesartan (up to Month 6)	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.
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14	Baseline, Month 3 and Last dose of Candesartan (up to Month 6)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Drug Reactions	Up to Month 3	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.