Essential Hypertension, Type 2 Diabetes Mellitus
Conditions
Keywords
Drug therapy
Brief 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.
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.
Interventions
Azilsartan medoxomil tablets
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. 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. 3. Has type 2 diabetes mellitus (T2DM) with essential hypertension. 4. 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. 5. Is male or female and aged 18 to 75 years, inclusive. 6. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg to \<180 mmHg, or diastolic blood pressure ≥85 mmHg and \<110 mmHg at screening and baseline. 7. Has screening glycosylated hemoglobin (HbA1C) \<9.5%. 8. 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.
Exclusion criteria
1. 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. 2. Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% at screening. 3. 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. 4. Has been previously treated with azilsartan medoxomil (AZM) or azilsartan. 5. Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome). 6. 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. 7. Has participated in a clinical trial including interventional and observational studies, or received any investigational compound currently or 30 days prior to screening. 8. Has severe renal impairment (based on estimated glomerular filtration rate \[GFR\] \<30 mL/min/1.73m\^2) at Screening. 9. Has hyperkalemia defined as serum potassium \>5.0 mEq/L. 10. Has an alanine aminotransferase (ALT) level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening. 11. 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. 12. Is taking prohibited medications including lithium and aliskiren (refer to Edarbi® product insert). 13. Has known hypersensitivity to any excipients or angiotensin converting enzyme inhibitor (ACEIs)/ angiotensin receptor blockers (ARBs). 14. Has prior angioedema due to an ACE inhibitor or ARB. 15. 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. 16. Have a history of alcohol abuse, drug abuse or illegal drug addiction within the 6 months prior to signing the informed consent. 17. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg | Weeks 6 and 12 | At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg | Weeks 6 and 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg | Weeks 6 and 12 | At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Treatment-Naïve Participants Reaching BP <130/80 mmHg | Up to Week 12 | 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. |
| Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg | Weeks 6 and 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg | Weeks 6 and 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg | Weeks 6 and 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Treatment-Naïve Participants Reaching BP <140/85 mmHg | Up to Week 12 | 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. |
| Percentage of Participants With BP <130/80 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants With SBP <130 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants With DBP <80 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Percentage of Participants With BP <140/90 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
| Change From Baseline in Trough Sitting SBP at Week 12 | Baseline and 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. |
| Change From Baseline in Trough Sitting SBP at Week 12 in Treatment-Naïve Participants | Baseline and 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. |
| Change From Baseline in DBP at Week 12 | Baseline and 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. |
| Change From Baseline in DBP at Week 12 in Treatment-Naïve Participants | Baseline and 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. |
| Percentage of Participants With DBP <90 mmHg at Week 12 | Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. |
Countries
China, Taiwan, Thailand
Participant flow
Recruitment details
Participants took part in the study at 34 investigative sites in Hong Kong, Taiwan and Thailand from 13 July 2015 to 25 November 2016.
Pre-assignment details
Participants with a diagnosis of essential hypertension and type 2 diabetes mellitus (T2DM) were enrolled to receive azilsartan medoxomil at a starting dose of 40 mg increased to 80 mg if blood pressure of \<140/85 mmHg was not achieved at Week 6.
Participants by arm
| Arm | Count |
|---|---|
| Azilsartan Medoxomil 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. | 380 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Investigator Decision | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Pretreatment Event/Adverse Event | 9 | 2 | 0 |
| Overall Study | Reason not specified | 2 | 0 | 0 |
| Overall Study | Significant Protocol Deviation | 4 | 1 | 0 |
| Overall Study | Voluntary Withdrawal | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Azilsartan Medoxomil |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 9.77 |
| Age, Customized >=65 to <75 years old | 159 Participants |
| Age, Customized < 65 years old | 221 Participants |
| Baseline Antihypertensive Treatment Status Other | 121 participants |
| Baseline Antihypertensive Treatment Status Treated with ACE inhibitor or ARB before Baseline | 202 participants |
| Baseline Antihypertensive Treatment Status Treated with CCB before Baseline | 112 participants |
| Baseline Antihypertensive Treatment Status Treated with Thiazide before Baseline | 30 participants |
| Body Mass Index (BMI) | 27.64 kg/m^2 STANDARD_DEVIATION 4.354 |
| Glycosylated Hemoglobin (HbA1c) | 7.00 mmoL/moL STANDARD_DEVIATION 0.875 |
| Height | 161.1 cm STANDARD_DEVIATION 9.57 |
| Race/Ethnicity, Customized Asian | 380 Participants |
| Region of Enrollment Hong Kong | 22 Participants |
| Region of Enrollment Taiwan, Province Of China | 139 Participants |
| Region of Enrollment Thailand | 219 Participants |
| Sex: Female, Male Female | 197 Participants |
| Sex: Female, Male Male | 183 Participants |
| Smoking history The participant has never smoked | 279 Participants |
| Smoking history The participant is a current smoker | 26 Participants |
| Smoking history The participant is an ex-smoker | 75 Participants |
| Weight | 72.04 kg STANDARD_DEVIATION 15.072 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 380 | 0 / 258 | 0 / 97 |
| serious Total, serious adverse events | 4 / 380 | 3 / 258 | 1 / 97 |
Outcome results
Primary
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.
Time frame: Week 12
Population: Full analysis set (FAS) included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using last observation carried forward (LOCF) method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | 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 | 59.8 percentage of participants |
| Azilsartan Medoxomil (Add-On) | 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 | 65.9 percentage of participants |
Secondary
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.
Time frame: Baseline and Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Change From Baseline in DBP at Week 12 | -4.9 mmHg | Standard Error 0.76 |
| Azilsartan Medoxomil (Add-On) | Change From Baseline in DBP at Week 12 | -5.7 mmHg | Standard Error 1.16 |
Secondary
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.
Time frame: Baseline and Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Change From Baseline in DBP at Week 12 in Treatment-Naïve Participants | 20 mmHg |
Secondary
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.
Time frame: Baseline and Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Change From Baseline in Trough Sitting SBP at Week 12 | -14.1 mmHg | Standard Error 1.39 |
| Azilsartan Medoxomil (Add-On) | Change From Baseline in Trough Sitting SBP at Week 12 | -13.3 mmHg | Standard Error 2.12 |
Secondary
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.
Time frame: Baseline and Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Change From Baseline in Trough Sitting SBP at Week 12 in Treatment-Naïve Participants | -7 mmHg |
Secondary
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.
Time frame: Weeks 6 and 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg | Week 6 | 31.1 percentage of participants |
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg | Week 12 | 35.2 percentage of participants |
Secondary
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.
Time frame: Weeks 6 and 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg | Week 6 | 63.7 percentage of participants |
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg | Week 12 | 63.7 percentage of participants |
Secondary
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.
Time frame: Weeks 6 and 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg | Week 6 | 57.8 percentage of participants |
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg | Week 12 | 52.3 percentage of participants |
Secondary
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.
Time frame: Weeks 6 and 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg | Week 6 | 26.6 percentage of participants |
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg | Week 12 | 27.5 percentage of participants |
Secondary
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.
Time frame: Weeks 6 and 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg | Week 6 | 41.4 percentage of participants |
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg | Week 12 | 51.7 percentage of participants |
Secondary
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.
Time frame: Weeks 6 and 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg | Week 6 | 79.3 percentage of participants |
| Azilsartan Medoxomil (Switched) | Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg | Week 12 | 86.2 percentage of participants |
Secondary
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.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With BP <130/80 mmHg at Week 12 | 33.7 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With BP <130/80 mmHg at Week 12 | 40.0 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With BP <130/80 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
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.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With BP <140/90 mmHg at Week 12 | 65.9 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With BP <140/90 mmHg at Week 12 | 68.2 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With BP <140/90 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
Percentage of Participants With DBP <80 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With DBP <80 mmHg at Week 12 | 57.6 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With DBP <80 mmHg at Week 12 | 65.9 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With DBP <80 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
Percentage of Participants With DBP <90 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With DBP <90 mmHg at Week 12 | 87.3 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With DBP <90 mmHg at Week 12 | 87.1 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With DBP <90 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
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.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 | 74.6 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 | 81.2 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
Percentage of Participants With SBP <130 mmHg at Week 12
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With SBP <130 mmHg at Week 12 | 41.3 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With SBP <130 mmHg at Week 12 | 43.5 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With SBP <130 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
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.
Time frame: Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 | 68.8 percentage of participants |
| Azilsartan Medoxomil (Add-On) | Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 | 70.6 percentage of participants |
| Azilsartan Medoxomil (Treatment-Naïve) | Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 | 0.0 percentage of participants |
Secondary
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.
Time frame: Up to Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Treatment-Naïve Participants Reaching BP <130/80 mmHg | 0.0 percentage of participants |
Secondary
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.
Time frame: Up to Week 12
Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil (Switched) | Percentage of Treatment-Naïve Participants Reaching BP <140/85 mmHg | 0.0 percentage of participants |