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

An observational study of Hypertension, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Candesartan Cilexetil
Type of treatment: Pill or oral medicine
How many people: 18,113 participants
Where: 1 siteJapan
Study dates: 13 Jun 2011to 25 Apr 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Hypertension

Who may be able to join

Hypertensive patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Osaka

Other trials in Japan

About this study

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

Read the 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.

Conditions: Hypertension
Being tested: Candesartan Cilexetil
Keywords: Drug Therapy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Candesartan CilexetilDrug
Also called Blopress
Candesartan Cilexetil tablet

Study groups in NCT02211638
Study group	Role	What they receive
Candesartan Cilexetil tablets (2 to 12 mg)		Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months Receives: Drug: Candesartan Cilexetil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Last dose of ARB Combination Drug (up to Month 6)

Secondary outcomes (1)

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.
Measured: Up to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201125 Apr 2013

First posted7 Aug 2014 (estimated)
Study start13 Jun 2011
Primary completion25 Apr 2013
Study completion25 Apr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 18,113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02211638
Sponsor's protocol ID: 460-017
Other IDs: JapicCTI-132380, JapicCTI-R171021
Status last verified: Apr 2018
First submitted: 17 Mar 2014
Last updated: 5 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blopress Tablets Special Drug Use Surveillance 「Challenge - Quality Control」
ClinicalTrials.gov ID: NCT02211638
Acronym / sponsor ID: 460-017
Conditions: Hypertension
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 18,113 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 13 Jun 2011 (actual)
Primary completion: 25 Apr 2013 (actual)
Study completion: 25 Apr 2013 (actual)
First posted: 7 Aug 2014 (estimated)
Results: Posted 5 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Candesartan Cilexetil tablets (2 to 12 mg)	–	Drug: Candesartan CilexetilCandesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Hypertension

Key inclusion criteria (1 listed)

Hypertensive patients

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Candesartan CilexetilAlso: BlopressCandesartan Cilexetil tablet	Drug	Candesartan Cilexetil tablets (2 to 12 mg)

Primary outcome

Changes in Clinic Blood Pressure in the Sitting Position
Time frame: 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
Time frame: 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.
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

Number of Participants Who Experience at Least One Adverse Drug Reactions
Time frame: Up to Month 3

Results and safety

Results posted to the registry on 5 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Candesartan Cilexetil 4 mg to 8 mg	18,113	17,130

Primary outcome: Changes in Clinic Blood Pressure in the Sitting Position

Time frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6). Mean (Standard Deviation). Unit: mmHg

Measure	Candesartan Cilexetil 4 mg to 8 mg n = 16617
Month 3, SBP	-20.1 (19.30)
Last Dose of Candesartan, SBP	-18.1 (18.91)
Month 3, DBP	-10.4 (12.34)
Last Dose of Candesartan, DBP	-9.3 (12.12)

Population analysed: Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was all participants in safety analysis set who were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint.

Primary outcome: Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14

Time frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6). Mean (Standard Deviation). Unit: mmHg

Measure	Candesartan Cilexetil 4 mg to 8 mg n = 11753
Month 3, SBP	-19.8 (18.74)
Last Dose of Candesartan, SBP	-19.5 (18.64)
Month 3, DBP	-10.1 (12.01)
Last Dose of Candesartan, DBP	-10.0 (12.03)

Population analysed: Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who continued candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint.

Primary outcome: Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14

Time frame: Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6). Mean (Standard Deviation). Unit: mmHg

Measure	Candesartan Cilexetil 4 mg to 8 mg n = 3630
Month 3, SBP	-21.7 (20.74)
Last Dose of Candesartan, SBP	-12.3 (18.83)
Last dose of ARB Combination Drug, SBP	-26.4 (20.49)
Month 3, DBP	-11.8 (13.26)
Last Dose of Candesartan, DBP	-6.4 (12.04)
Last dose of ARB Combination Drug, DBP	-14.4 (13.45)

Population analysed: Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint.

Primary outcome: Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14

Time frame: Baseline and Last dose of ARB Combination Drug (up to Month 6). Mean (Standard Deviation). Unit: mmHg

Measure	Candesartan Cilexetil 4 mg to 8 mg n = 984
SBP	-24.5 (20.20)
DBP	-13.2 (13.62)

Population analysed: Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Month 3. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Candesartan Cilexetil 4 mg to 8 mg	36 of 17,130 (0.2%)	41 of 17,130 (0.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypertension

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Clinic Blood Pressure in the Sitting Position (time frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02211638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.