Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azilsartan medoxomil and chlorthalidone · 6 trials · 2 indications
The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.
The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality.
The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
| Arm | Type | Description |
|---|---|---|
| Azilsartan medoxomil 40 mg | EXPERIMENTAL | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
| Azilsartan medoxomil 80 mg | EXPERIMENTAL | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
| Valsartan 160 mg | ACTIVE_COMPARATOR | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
| Azilsartan Medoxomil + Chlorthalidone | EXPERIMENTAL | United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets, titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks. |
| Olmesartan Medoxomil + Hydrochlorothiazide | ACTIVE_COMPARATOR | United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | EXPERIMENTAL | - |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | EXPERIMENTAL | - |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | ACTIVE_COMPARATOR | - |
| Azilsartan Medoxomil and Chlorthalidone | EXPERIMENTAL | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. |
| Olmesartan Medoxomil and Hydrochlorothiazide QD | ACTIVE_COMPARATOR | Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. |
| Azilsartan Medoxomil 20-40mg plus Chlorthalidone 12.5-25 mg QD | EXPERIMENTAL | (dependant on blood pressure) |
| Azilsartan Medoxomil 40-80mg plus Chlorthalidone 12.5-25 mg QD | EXPERIMENTAL | (dependant on blood pressure) |
| Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | EXPERIMENTAL | - |
| Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Azilsartan medoxomil | DRUG | Azilsartan medoxomil tablets |
| Valsartan | DRUG | Valsartan 80 mg capsules |
| Azilsartan medoxomil Placebo | DRUG | Azilsartan medoxomil placebo-matching tablets |
| Valsartan Placebo | DRUG | Valsartan placebo-matching capsules |
| Azilsartan medoxomil and chlorthalidone | DRUG | Fixed-dose combination tablets. |
| Olmesartan medoxomil and hydrochlorothiazide | DRUG | Fixed-dose combination tablets. |
| Olmesartan medoxomil-hydrochlorothiazide | DRUG | Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks. If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks. |
| Azilsartan medoxomil and hydrochlorothiazide | DRUG | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
Inclusion Criteria: 1. Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure (SBP) ≥150 and ≤180 mm Hg on Day 1; or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic SBP ≥...
Azilsartan Medoxomil is an investigational small molecule being developed for the treatment of essential hypertension and hypertension. It is in Phase 3 clinical development, with completed trials evaluating its efficacy and safety in patients with moderate to severe hypertension.
Azilsartan Medoxomil is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 3 clinical development for hypertension and essential hypertension.
Azilsartan Medoxomil is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All 11 clinical trials for the drug have been completed, with no active trials currently ongoing.
Azilsartan Medoxomil has completed 11 Phase 3 clinical trials, including NCT00818883, NCT01033071, NCT01309828, and NCT02480764. These trials evaluated the drug alone or in combination with chlorthalidone, compared to other antihypertensive regimens, in patients with essential hypertension and kidney disease.
Yes, Azilsartan Medoxomil is also known as TAK-491. In clinical trials, it has been studied under this alternative name, such as in the trial NCT02480764, which compared TAK-491 to valsartan in Chinese participants with hypertension.