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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211638
• Other study ID #: 460-017
• Secondary ID: JapicCTI-132380J
• Status: Completed
• Start date: June 13, 2011
• Est. completion date: April 25, 2013

Study information

• Verified date: April 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18113
• Est. completion date: April 25, 2013
• Est. primary completion date: April 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Candesartan Cilexetil
Candesartan Cilexetil tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
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	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	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