Essential HypertensionPhase 4NCT02517866
Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia
A Phase 4 study testing Azilsartan Medoxomil in people with Essential Hypertension and Type 2 Diabetes Mellitus, run by Takeda at 11 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension, Type 2 Diabetes Mellitus
- What is being tested?
- Azilsartan Medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 13 Jul 2015to 25 Nov 2016
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has type 2 diabetes mellitus (T2DM) with essential hypertension.
- T2DM participants are either treated by stable life style intervention or by oral antidiabetic drugs (OADs) that are stable, including no dose adjustment within 12 weeks before baseline.
- Is male or female and aged 18 to 75 years, inclusive.
- Uncontrolled hypertension (systolic blood pressure ≥140 mmHg to <180 mmHg, or diastolic blood pressure ≥85 mmHg and <110 mmHg at screening and baseline.
- Has screening glycosylated hemoglobin (HbA1C) <9.5%.
- Female participants must be either of non-childbearing potential, ie, surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year after the last menstrual period; or, if of childbearing potential and participant is sexually active with a nonsterilized male partner, must agree to use routinely adequate contraception from signing of informed consent throughout the duration of study.
Who cannot join
- Has systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite concurrent treatment with three antihypertensive medications from different classes at adequate doses including a diuretic.
- Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% at screening.
- Is treated with OADs has not been on stable treatment including no dose change of their OADs for at least 12 weeks prior to baseline.
- Has been previously treated with azilsartan medoxomil (AZM) or azilsartan.
- Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
- Has congestive heart failure (New York Heart Association class III or IV), clinically relevant cardiac arrhythmias (as determined by the investigator's clinical judgment on a participant-by-participant basis), severe obstructive coronary artery disease.
Show all 17Show fewer
- Has participated in a clinical trial including interventional and observational studies, or received any investigational compound currently or 30 days prior to screening.
- Has severe renal impairment (based on estimated glomerular filtration rate [GFR] <30 mL/min/1.73m^2) at Screening.
- Has hyperkalemia defined as serum potassium >5.0 mEq/L.
- Has an alanine aminotransferase (ALT) level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening.
- Has any clinically relevant disease (eg malignancy, neurological, hepatic abnormalities) and/or significant abnormal laboratory findings (past or present), which, in the opinion of the investigator, may put the participant at risk because of participation in the study.
- Is taking prohibited medications including lithium and aliskiren (refer to Edarbi® product insert).
- Has known hypersensitivity to any excipients or angiotensin converting enzyme inhibitor (ACEIs)/ angiotensin receptor blockers (ARBs).
- Has prior angioedema due to an ACE inhibitor or ARB.
- Breast feeding or pregnant women or women who are intending to become pregnant before, during or within 1 month after participating in the study; or intending to donate ova during such time period, or refusal to submit to a urine test to rule out pregnancy prior to enrolment and at end of study.
- Have a history of alcohol abuse, drug abuse or illegal drug addiction within the 6 months prior to signing the informed consent.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Taiwan6 sites
Study site
Changhua County
Study site
Kaohsiung City
Study site
Taichung
Study site
Tainan
Study site
Taipei
Study site
Taoyuan County
Thailand4 sites
Study site
Bangkok
Study site
Chiang Mai
Study site
Khon Kaen
Study site
Pathum Thani
About this study
Official title: A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.
Read the detailed description
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have essential hypertension and type 2 diabetes mellitus (T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in addition to standard care for T2DM.
The study will enroll approximately 380 patients. All participants will receive azilsartan medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a participant's blood pressure (BP) has not reached BP goal of <140/85 mmHg at week 6, azilsartan medoxomil dose will be up-titrated to 80 mg daily.
All participants will be asked to take one tablet at the same time each day throughout the study.
This multi-center trial will be conducted in Asia. The overall time to participate in this study is 14 weeks. Participants will make multiple visits to the clinic, and will be contacted by 14 days after last dose of study drug for a follow-up assessment.
- Conditions
- Essential Hypertension, Type 2 Diabetes Mellitus
- Being tested
- Azilsartan Medoxomil
- Keywords
- Drug therapy
- Medical subject headings
- Essential Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan MedoxomilDrug
Also called Edarbi®
Azilsartan medoxomil tablets
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan medoxomil | Experimental | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Receives: Drug: Azilsartan Medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Secondary outcomes (19)
Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg
Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Up to Week 12
Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg
At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Weeks 6 and 12
Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Weeks 6 and 12
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg
At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Weeks 6 and 12
Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg
Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Up to Week 12
Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Weeks 6 and 12
Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Weeks 6 and 12
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Weeks 6 and 12
Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Percentage of Participants With DBP <90 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Percentage of Participants With BP <130/80 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Percentage of Participants With SBP <130 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Percentage of Participants With DBP <80 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Percentage of Participants With BP <140/90 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Measured: Week 12
Change From Baseline in Trough Sitting SBP at Week 12
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Measured: Baseline and Week 12
Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Measured: Baseline and Week 12
Change From Baseline in DBP at Week 12
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Measured: Baseline and Week 12
Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start13 Jul 2015
- Primary completion15 Nov 2016
- Study completion25 Nov 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 Essential 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517866
- Sponsor's protocol ID
- AZI-P4-002
- Other IDs
- U1111-1156-8501
- Status last verified
- Oct 2018
- First submitted
- 24 Jun 2015
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia
- ClinicalTrials.gov ID
- NCT02517866
- Acronym / sponsor ID
- AZI-P4-002
- Conditions
- Essential Hypertension, Type 2 Diabetes Mellitus
- Keywords
- Drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.
Detailed description
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have essential hypertension and type 2 diabetes mellitus (T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in addition to standard care for T2DM.
The study will enroll approximately 380 patients. All participants will receive azilsartan medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a participant's blood pressure (BP) has not reached BP goal of <140/85 mmHg at week 6, azilsartan medoxomil dose will be up-titrated to 80 mg daily.
All participants will be asked to take one tablet at the same time each day throughout the study.
This multi-center trial will be conducted in Asia. The overall time to participate in this study is 14 weeks. Participants will make multiple visits to the clinic, and will be contacted by 14 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azilsartan medoxomil | Experimental | Drug: Azilsartan MedoxomilAzilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has type 2 diabetes mellitus (T2DM) with essential hypertension.
- T2DM participants are either treated by stable life style intervention or by oral antidiabetic drugs (OADs) that are stable, including no dose adjustment within 12 weeks before baseline.
- Is male or female and aged 18 to 75 years, inclusive.
Key exclusion criteria (17 listed)
- Has systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite concurrent treatment with three antihypertensive medications from different classes at adequate doses including a diuretic.
- Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% at screening.
- Is treated with OADs has not been on stable treatment including no dose change of their OADs for at least 12 weeks prior to baseline.
- Has been previously treated with azilsartan medoxomil (AZM) or azilsartan.
- Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
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 |
|---|---|---|
| Azilsartan MedoxomilAlso: Edarbi®Azilsartan medoxomil tablets | Drug | Azilsartan medoxomil |
Primary outcome
Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12
Time frame: Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
19 secondary outcomes
Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg
Time frame: Up to Week 12
Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg
Time frame: Weeks 6 and 12
Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg
Time frame: Weeks 6 and 12
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg
Time frame: Weeks 6 and 12
Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg
Time frame: Up to Week 12
Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg
Time frame: Weeks 6 and 12
Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg
Time frame: Weeks 6 and 12
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg
Time frame: Weeks 6 and 12
Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12
Time frame: Week 12
Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12
Time frame: Week 12
Percentage of Participants With DBP <90 mmHg at Week 12
Time frame: Week 12
Percentage of Participants With BP <130/80 mmHg at Week 12
Time frame: Week 12
Percentage of Participants With SBP <130 mmHg at Week 12
Time frame: Week 12
Percentage of Participants With DBP <80 mmHg at Week 12
Time frame: Week 12
Percentage of Participants With BP <140/90 mmHg at Week 12
Time frame: Week 12
Change From Baseline in Trough Sitting SBP at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants
Time frame: Baseline and Week 12
Change From Baseline in DBP at Week 12
Time frame: Baseline and Week 12
Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director Clinical Science study director
Takeda
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azilsartan Medoxomil in people with Essential Hypertension and Type 2 Diabetes Mellitus, run by Takeda at 11 sites in 3 countries.
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 8 inclusion and 17 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 1 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 11 sites in Taiwan, Thailand, China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 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?
Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2019.