A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension

Figures

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  Figure 1. Study design. ∗The screening visit was scheduled before the washout/run-in period so that laboratory tests results were reviewed and patient eligibility confirmed before other treatments were stopped or placebo was initiated. †Patients were notified by telephone to begin the washout period. ‡Patients taking previous antihypertensive agents were required to participate in a 3-week washout/run-in period (days −21–−1). §If the subject's previous antihypertensive treatment included amlodipine or chlorthalidone, the washout was extended to 4 weeks (days −28–−1). ‖The first dose of placebo was taken at the clinic on day −14 (visit 2). ∗∗Patients who had not received antihypertensive treatment within 28 days before screening were entered into the run-in period as soon as all inclusion and exclusion criteria, including laboratory results, were verified. ††The last dose of double-blind treatment was the day of week 8/final clinic visit or ET (visit 9); patients in the ABPM subgroup started 24-hour ABPM measurement. ‡‡The follow-up telephone contact was made approximately 14 days after the last dose. §§Visit 4 applied to ABPM subgroup patients only, who started 24-hour ABPM measurement.…

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  Figure 2. Consort flow diagram. ∗Patients who completed the study were the total number randomized per treatment group minus those who discontinued. †Patients could have had more than 1 reason for discontinuation; only the primary reason is presented. AE = adverse event, AZL-M = azilsartan medoxomil, PTE = pretreatment event.

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  Figure 3. Least squares mean (standard error) change from baseline to week 8 in trough sitting clinic systolic blood pressure and sitting clinic diastolic blood pressure (full analysis set, last observation carried forward). ∗Indicates P≤.01 compared with valsartan 160 mg. +Values in parentheses are the least squares mean difference between azilsartan medoxomil and valsartan. FAS = full analysis set, LOCF = last observation carried forward, LS = least squares, scDBP = sitting clinic diastolic blood pressure, scSBP = sitting clinic systolic blood pressure, SE = standard error.

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  Figure 4. Change from baseline in trough sitting clinic systolic blood pressure and sitting clinic diastolic blood pressure at weeks 2, 4, 6, and 8 (full analysis set, last observation carried forward). ∗P < .05. ∗∗P≤.01. ∗∗∗P≤.001. FAS = full analysis set, LOCF = last observation carried forward, scDBP = sitting clinic diastolic blood pressure, scSBP = sitting clinic blood pressure.

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  Figure 5. Hourly systolic blood pressure (A) and diastolic blood pressure (B) ambulatory blood pressure monitoring data at week 8. ABPM = ambulatory blood pressure monitoring, AZL-M = azilsartan medoxomil, DBP = diastolic blood pressure, LS = least squares, SBP = systolic blood pressure, SE = standard error.