Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"

An observational study of Hypertension, run by Takeda.

Completed

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

Trial summary

The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence… Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Hypertension
What is being tested?: candesartan cilexetil
Type of treatment: Pill or oral medicine
How many people: 14,151 participants
Where: No sites listed yet
Study dates: Jun 2006to Nov 2010
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 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hypertension

Inclusion Criteria: Hypertensive patients with at least one of the following risk factors:

Waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female
Fasting triglyceride level ≥ 150 milligram per deciliter (mg/dL)
High-density lipoprotein (HDL) cholesterol level less than (<) 40 mg/dL
Fasting blood glucose level ≥ 110 mg/dL
Body-mass index (BMI) ≥ 25.0 * Patients currently taking medications for hypertriglyceridemia, hypo-HDL-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance

Exclusion Criteria: Hypertensive patients who meet all of the following conditions ([1] to [3]):

Patients receiving continuous therapy with Blopress Tablets
Patients aged < 20 years or ≥ 75 years
Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance

About this study

Official title: Candesartan Cilexetil Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"

Read the detailed description

This survey was designed to investigate the treatment status of hypertensive patients with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

For adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. The dose is increased up to 12 mg, as necessary. For patients with complications of renal damage, however, administration of candesartan cilexetil should be started at 2 mg once daily, and, as necessary, the dose increased up to 8 mg.

Conditions: Hypertension
Being tested: candesartan cilexetil
Keywords: Pharmacological 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 Tablets
candesartan cilexetil tablets

Study groups in NCT02166697
Study group	Role	What they receive
Oral administration of 4-8 mg of candesartan cilexetil		Oral administration of 4-8 milligram (mg) of candesartan cilexetil once daily (increased up to 12 mg, as necessary) Receives: Drug: candesartan cilexetil

What is being measured

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

Number of Participants Reporting One or More Adverse Drug Reactions (ADR)
ADR 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.
Measured: Baseline up to 3 years
Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)
SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to 3 years

Secondary outcomes (4)

Incidence of Cerebrovascular/Cardiovascular Events
Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Measured: Baseline up to 3 years
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities
Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Measured: Baseline up to 3 years
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities
Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Measured: Baseline up to 3 years
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities
Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Measured: Baseline up to 3 years

Timeline

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

Jun 2006Nov 2010

First posted18 Jun 2014 (estimated)
Study startJun 2006
Primary completionNov 2010
Study completionNov 2010

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: 14,151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02166697
Sponsor's protocol ID: 460-015
Other IDs: JapicCTI-142567, JapicCTI-R160847
Status last verified: Sep 2016
First submitted: 16 Jun 2014
Last updated: 28 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Trial Phase: Syndemic Adapted Medly Uganda
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Candesartan Cilexetil Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
ClinicalTrials.gov ID: NCT02166697
Acronym / sponsor ID: 460-015
Conditions: Hypertension
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 14,151 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 18 Jun 2014 (estimated)
Results: Posted 11 Jul 2016

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
Oral administration of 4-8 mg of candesartan cilexetil	–	Drug: candesartan cilexetilOral administration of 4-8 milligram (mg) of candesartan cilexetil once daily (increased up to 12 mg, as necessary)

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hypertension

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: Blopress Tabletscandesartan cilexetil tablets	Drug	Oral administration of 4-8 mg of candesartan cilexetil

Primary outcome

Number of Participants Reporting One or More Adverse Drug Reactions (ADR)
Time frame: Baseline up to 3 years
ADR 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.
Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)
Time frame: Baseline up to 3 years
SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

4 secondary outcomes

Incidence of Cerebrovascular/Cardiovascular Events
Time frame: Baseline up to 3 years
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities
Time frame: Baseline up to 3 years
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities
Time frame: Baseline up to 3 years
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities
Time frame: Baseline up to 3 years

Results and safety

Results posted to the registry on 11 Jul 2016, 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	14,151	13,804

Primary outcome: Number of Participants Reporting One or More Adverse Drug Reactions (ADR)

Time frame: Baseline up to 3 years. Number. Unit: Participants

Measure	Candesartan Cilexetil n = 13804
Value	230

Population analysed: The safety analysis set was defined as all participants who were enrolled and completed the study.

Primary outcome: Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)

Time frame: Baseline up to 3 years. Number. Unit: Participants

Measure	Candesartan Cilexetil n = 13804
Value	320

Population analysed: The safety analysis set was defined as all participants who were enrolled and completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Candesartan Cilexetil	320 of 13,804 (2.3%)	230 of 13,804 (1.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Postmarketing Group Manager study chair

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Takeda.

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

Who may be eligible to take part?

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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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 11 Jul 2016). 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?

Number of Participants Reporting One or More Adverse Drug Reactions (ADR) (time frame: Baseline up to 3 years). The study lists 2 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 NCT02166697.

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 28 Sep 2016.