Table 1 Clinical trials conducted with Azilsartan to date (Phase III)

Sica et al. 2011 [7]

24

984 patients

AZM 40 mg/d (n=327)

Change in 24-hour

AZM 40 mg/d: -14.9 mmHg

Mean age: 58 years

AZM 80 mg/d (n=329)

mean SBP from baseline to week 24

AZM 80 mg/d: -15.3 mmHg

Female: 48%

Val 320 mg/d (n=328)

Val 320 mg/d: -11,3 mmHg

BMI: 31 kg/m²

(p<0.001)

Race: 77% Caucasian

White et al. 2011 [6]

6

1291 patients

AZM 40 mg/d (n=280)

Change in 24-hour

mean SBP from baseline to week 24

AZM 40 mg/d: -13.4 mmHg

Mean age: 56 years

AZM 80 mg/d (n=285)

AZM 80 mg/d: -14.5 mmHg (p=0.009 vs. OLM, p<0.001 vs. VAL)

Female: 46%

Valsartan 320 mg/d (n=282)

BMI: 31 kg/m²

Olmesartan 40 mg/d (n=290)

Valsartan 320 mg/d: -10.2 mmHg

Race: 65% Caucasian

Placebo (n=154)

Olmesartan 40 mg/d: -12.0 mmHg

Placebo: -0.3 mmHg

Bakris et al. 2011 [8]

6

1275 patients

AZM 20 mg/d (n=283)

AZM 20 mg/d: -12.2 mmHg

Mean age: 50 years

AZM 40 mg/d (n=283)

AZM 40 mg/d: -13.5 mmHg

Female: 50%

AZM 80 mg/d (n=285)

AZM 80 mg/d: -14.6 mmHg

BMI: 30 kg/m²

OLM 40 mg/d (n=282)

(p=0.038 vs. OLM))

Race: 73% Caucasian

Placebo (n=142)

Change in 24-hour mean SBP from baseline to week 6

OLM 40 mg/d:-12.6 mmHg

Placebo: -1.4 mmHg

Rakugi et al. 2012 [9]

16

622 patients

Azilsartan up to 40 mg/d (n=313)

Change in sitting trough clinic DBP from baseline to week 16 (LOCF)

Azilsartan: -12.9 mmHg

Mean age: 57 years

Candesartan up to 12 mg/d (n=309)

Candesartan: -9.7 mmHg

Female: 39%

(p=0.0003)

BMI: 25.5 kg/m²

(SBP reduction at week 16: AZM –

Race: 100% Japanese

21.6 mmHg, CAN −17.3 mmHg)

Bönner et al. 2013 [11]

24

884 patients

AZM 40 mg/d (n=295)

Change in sitting trough clinic SBP from baseline to week 24

AZM 40 mg: -10,2 mmHg

Mean age: 57 years

AZM 80 mg/d (n=294)

AZM 80 mg: -10,5 mmHg

Female: 48%

Rami 10 mg/d (n=295)

Rami 10 mg: -4,9 mmHg

BMI: 30 kg/m²

(clinic SBPp<0.001)

Race: >99% Caucasian