Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02203916 | Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension | PHASE3 | COMPLETED | 328 | — | — | Jul 1, 2014 | Feb 1, 2016 | Dec 19, 2016 | 15 | South Korea |
| NCT00847626 | Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension | PHASE3 | COMPLETED | 1,711 | — | — | Jan 1, 2009 | Jul 1, 2010 | Feb 7, 2012 | 99 | United States, Chile +3 |
| NCT00696436 | An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension. | PHASE3 | COMPLETED | 1,291 | — | — | Apr 1, 2008 | Aug 1, 2009 | Apr 19, 2011 | 131 | United States, Argentina +4 |
| NCT00760214 | Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension | PHASE3 | COMPLETED | 885 | — | — | Jan 1, 2008 | Apr 1, 2009 | Nov 15, 2012 | 72 | Bulgaria, Estonia +8 |
| NCT00591578 | Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension | PHASE3 | COMPLETED | 984 | — | — | Dec 1, 2007 | Mar 1, 2010 | Feb 2, 2012 | 88 | United States, Chile +2 |
| NCT00591253 | Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension | PHASE3 | COMPLETED | 413 | — | — | Oct 1, 2007 | Apr 1, 2009 | Apr 19, 2011 | 64 | United States, Puerto Rico |
| NCT00591266 | Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension | PHASE3 | COMPLETED | 566 | — | — | Oct 1, 2007 | Apr 1, 2009 | Jul 22, 2011 | 50 | United States |
| NCT00591773 | Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension | PHASE3 | COMPLETED | 551 | — | — | Sep 1, 2007 | Mar 1, 2009 | Apr 19, 2011 | 46 | United States |
| NCT00696241 | Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension | PHASE3 | COMPLETED | 1,275 | — | — | Jun 1, 2007 | Oct 1, 2008 | Jul 29, 2011 | 85 | United States, Argentina +1 |
| NCT00696384 | A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension | PHASE3 | COMPLETED | 418 | — | — | Jun 1, 2007 | Apr 1, 2009 | Jan 4, 2012 | 45 | United States, Argentina +1 |
| NCT00362115 | Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension | PHASE2 | COMPLETED | 449 | — | — | May 1, 2006 | Dec 1, 2006 | Apr 19, 2011 | 54 | United States, Argentina +2 |
The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
The change in sitting clinic diastolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.
The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
| Arm | Type | Description |
|---|---|---|
| Azilsartan Medoxomil 40 mg | EXPERIMENTAL | Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. |
| Azilsartan Medoxomil 80 mg | EXPERIMENTAL | Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks. |
| Azilsartan medoxomil 20 mg/chlorthalidone 12.5 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 20 mg/chlorthalidone 25 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 40 mg/chlorthalidone 12.5 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 40 mg/chlorthalidone 25 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 80 mg/chlorthalidone 12.5 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 80 mg/chlorthalidone 25 mg QD | EXPERIMENTAL | - |
| Chlorthalidone 12.5 mg QD | ACTIVE_COMPARATOR | - |
| Chlorthalidone 25 mg QD | ACTIVE_COMPARATOR | - |
| Azilsartan medoxomil 20 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 40 mg QD | EXPERIMENTAL | - |
| Azilsartan medoxomil 80 mg QD | EXPERIMENTAL | - |
| Valsartan 320 mg QD | ACTIVE_COMPARATOR | - |
| Olmesartan 40 mg QD | ACTIVE_COMPARATOR | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Ramipril 10 mg QD | ACTIVE_COMPARATOR | - |
| Azilsartan Medoxomil 40 mg QD and Amlodipine 5 mg QD | EXPERIMENTAL | - |
| Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD | EXPERIMENTAL | - |
| Amlodipine 5 mg QD | ACTIVE_COMPARATOR | - |
| Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD | EXPERIMENTAL | - |
| Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD | EXPERIMENTAL | - |
| Azilsartan Medoxomil QD-Open Label Phase (Baseline - Week 26) | EXPERIMENTAL | - |
| Azilsartan Medoxomil QD - Double-Blind Phase (Week 26-32) | EXPERIMENTAL | - |
| Placebo QD - Double-Blind Phase (Week 26- 32) | PLACEBO_COMPARATOR | - |
| Azilsartan Medoxomil 5 mg QD | EXPERIMENTAL | - |
| Azilsartan Medoxomil 10 mg QD | EXPERIMENTAL | - |
| Olmesartan 20 mg QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Azilsartan medoxomil | DRUG | Azilsartan medoxomil tablets |
| Azilsartan medoxomil placebo | DRUG | Azilsartan medoxomil placebo-matching tablets |
| Azilsartan medoxomil and chlorthalidone | DRUG | Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks |
| Chlorthalidone | DRUG | Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks |
| Valsartan | DRUG | Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks. Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks. |
| Olmesartan | DRUG | Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks. Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks. |
| Placebo | DRUG | Matching placebo, orally, once daily for up to six weeks. |
| Ramipril | DRUG | Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks. |
| Azilsartan Medoxomil and amlodipine | DRUG | Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. |
| Amlodipine | DRUG | Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. |
| Azilsartan medoxomil and olmesartan | DRUG | Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks. |
| Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications. | DRUG | Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks/Week 32. |
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 requi...