Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

An observational study of Hypertension, run by Takeda at 2 sites 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 evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Azilsartan
Type of treatment: Pill or oral medicine
How many people: 387 participants
Where: 2 sitesJapan
Study dates: 3 Mar 2014to 29 Feb 2016
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

Patients with hypertension who meet all the following criteria will be enrolled:
Patients who has complications of diabetes mellitus
Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
Patients who is an outpatient
Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.
For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).

Who cannot join

Patients with contraindications to azilsartan

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

Official title: Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

Read the detailed description

This study was designed to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with ARBs, other than azilsartan, in daily medical practice.

Patient enrollment will be started on April 1, 2014. The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the participant's age and condition. The maximum daily dose is 40 mg.

Conditions: Hypertension
Being tested: Azilsartan
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.

AzilsartanDrug
Also called Azilva Tablets
Azilsartan tablets

Study groups in NCT02100319
Study group	Role	What they receive
Azilsartan at a dose of 20 to 40 mg, orally, once daily		Azilsartan tablets Receives: Drug: Azilsartan

What is being measured

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

Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution
Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution.
Measured: From baseline up to final assessment point (up to Week 24)
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)
Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.
Measured: From baseline up to final assessment point (up to Week 24)

Secondary outcomes (4)

Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution
Reported data were changes from baseline in pulse rate measured at the medical institution.
Measured: From baseline up to final assessment point (up to Week 24)
Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution
Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program [NGSP] value) measured at the Medical Institution.
Measured: From baseline up to final assessment point (up to Week 24)
Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution
Reported data were changes from baseline in creatinine-adjusted urinary albumin level (that is calculated from urinary albumin level divided by creatinine level) measured at the medical institution. Here "mg/gCr" is Milligrams per Gram of Creatinine.
Measured: From baseline up to final assessment point (up to Week 24)
Percentage of Participants Who Had One or More Adverse Events
Measured: Up to Week 24

Timeline

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

3 Mar 201429 Feb 2016

First posted31 Mar 2014 (estimated)
Study start3 Mar 2014
Primary completion29 Feb 2016
Study completion29 Feb 2016

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: 387 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02100319
Sponsor's protocol ID: 279-012
Other IDs: JapicCTI-142466
Status last verified: Dec 2018
First submitted: 6 Mar 2014
Last updated: 21 Mar 2019
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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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
ClinicalTrials.gov ID: NCT02100319
Acronym / sponsor ID: 279-012
Conditions: Hypertension
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 387 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 3 Mar 2014 (actual)
Primary completion: 29 Feb 2016 (actual)
Study completion: 29 Feb 2016 (actual)
First posted: 31 Mar 2014 (estimated)
Results: Posted 21 Mar 2019

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
Azilsartan at a dose of 20 to 40 mg, orally, once daily	–	Drug: AzilsartanAzilsartan tablets

Who may qualify

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

Key inclusion criteria (7 listed)

Patients with hypertension who meet all the following criteria will be enrolled:
For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).

Key exclusion criteria (1 listed)

Patients with contraindications to azilsartan

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
AzilsartanAlso: Azilva TabletsAzilsartan tablets	Drug	Azilsartan at a dose of 20 to 40 mg, orally, once daily

Primary outcome

Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution
Time frame: From baseline up to final assessment point (up to Week 24)
Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution.
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)
Time frame: From baseline up to final assessment point (up to Week 24)
Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.

4 secondary outcomes

Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution
Time frame: From baseline up to final assessment point (up to Week 24)
Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution
Time frame: From baseline up to final assessment point (up to Week 24)
Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution
Time frame: From baseline up to final assessment point (up to Week 24)
Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Week 24

Results and safety

Results posted to the registry on 21 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azilsartan 20 to 40 mg	387	371

Primary outcome: Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution

Time frame: From baseline up to final assessment point (up to Week 24). Mean (Standard Deviation). Unit: Millimeter of Mercury (mmHg)

Measure	Azilsartan 20 to 40 mg n = 371
Systolic Blood Pressure (SBP)	-10.5 (18.40)
Diastolic Blood Pressure (DBP)	-5.1 (11.57)

Population analysed: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.

Primary outcome: Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)

Time frame: From baseline up to final assessment point (up to Week 24). Mean (Standard Deviation). Unit: mmHg

Measure	Azilsartan 20 to 40 mg n = 371
SBP Right after Waking-up	-7.9 (14.86)
DBP Right after Waking-up	-4.1 (8.07)
SBP at Bedtime	-7.1 (13.82)
DBP at Bedtime	-4.3 (7.76)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azilsartan 20 to 40 mg	5 of 371 (1.3%)	20 of 371 (5.4%)	2 of 371

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Study Director study director

Takeda

2 sites 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 2 sites 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 7 inclusion and 1 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 21 Mar 2019). 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 From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution (time frame: From baseline up to final assessment point (up to Week 24)). 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 NCT02100319.

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 21 Mar 2019.