18 and older, any sex, with Essential Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP)Primary· Baseline and Week 8
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.
Baseline SBP
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
157.873
± 0.5123
Azilsartan Medoxomil 80 mg
158.236
± 0.5010
Valsartan 160 mg
158.594
± 0.5123
Change at Week 8
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
-22.483
± 1.0258
Azilsartan Medoxomil 80 mg
-24.236
± 1.0027
Valsartan 160 mg
-20.551
± 1.0258
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP)Secondary· Baseline and Week 8
The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP 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.
Baseline DBP
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
91.790
± 0.7306
Azilsartan Medoxomil 80 mg
91.510
± 0.7145
Valsartan 160 mg
92.298
± 0.7306
Change at Week 8
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
-10.101
± 0.6684
Azilsartan Medoxomil 80 mg
-11.463
± 0.6538
Valsartan 160 mg
-8.641
± 0.6686
Percentage of Participants Who Achieved a Clinic SBP Response at Week 8Secondary· Week 8
Clinic SBP response was defined as clinic SBP \<140 mm Hg and/or reduction of ≥20 mm Hg from Baseline. 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.
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
67.0
Azilsartan Medoxomil 80 mg
68.9
Valsartan 160 mg
69.0
Percentage of Participants Who Achieved a Clinic DBP Response at Week 8Secondary· Week 8
Clinic DBP response was defined as clinic DBP \<90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. 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.
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
81.2
Azilsartan Medoxomil 80 mg
81.6
Valsartan 160 mg
79.7
Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8Secondary· Week 8
Clinic SBP response was defined as clinic SBP \<140 mm Hg and/or reduction of ≥20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP \<90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. 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.
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
62.9
Azilsartan Medoxomil 80 mg
67.0
Valsartan 160 mg
64.5
Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8Secondary· Week 8
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.
Clinic SBP <140 mm Hg
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
60.9
Azilsartan Medoxomil 80 mg
62.6
Valsartan 160 mg
62.9
Clinic DBP <90 mm Hg
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
77.2
Azilsartan Medoxomil 80 mg
76.7
Valsartan 160 mg
74.6
Clinic SBP <140 mm Hg and DBP <90 mm Hg
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
58.4
Azilsartan Medoxomil 80 mg
60.2
Valsartan 160 mg
55.8
Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8Secondary· Week 8
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.
Clinic SBP <130 mm Hg
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
37.6
Azilsartan Medoxomil 80 mg
42.7
Valsartan 160 mg
28.4
Clinic DBP <80 mm Hg
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
45.2
Azilsartan Medoxomil 80 mg
51.9
Valsartan 160 mg
37.1
Clinic SBP <130 mm Hg and DBP <80 mm Hg
Group
Value
95% CI
Azilsartan Medoxomil 40 mg
28.9
Azilsartan Medoxomil 80 mg
33.0
Valsartan 160 mg
21.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through 14 days after the last dose of study drug (Up to Week 12).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Azilsartan Medoxomil 40 mg
Serious: 2/199 (1%)
Deaths: 1/199
Azilsartan Medoxomil 80 mg
Serious: 7/209 (3%)
Deaths: 0/209
Valsartan 160 mg
Serious: 6/204 (3%)
Deaths: 0/204
Serious adverse events (12 terms)
Reaction
System
Azilsartan Medoxomil 40 mg
Azilsartan Medoxomil 80 mg
Valsartan 160 mg
Peptic ulcer haemorrhage
Gastrointestinal disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Meniscus injury
Injury, poisoning and procedural complications
—
—
—
Subarachnoid haemorrhage
Injury, poisoning and procedural complications
—
—
—
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
—
—
—
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 5 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02480764.