A Clinical Study to Evaluate the Efficacy and Safety of Azilsartan Amlodipine Tablets in Patients With Essential Hypertension

Efficacy and Safety of Azilsartan Amlodipine Tablets in Patients With Essential Hypertension: A randomized, double-blind, double-dummy, active-controlled, parallel-group, multicenter study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600127558

Enrollment

Unknown

Registered

2026-07-02

Start date

2026-04-14

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

essential hypertension

Interventions

Test group:Azilsartan and Amlodipine Besylate Tablets 20mg/5mg+Allisartan Isoproxil and Amlodipine Besylate Tablets Matching Placebo

Control group :Allisartan Isoproxil and Amlodipine Besylate Tablets 240mg/5mg+Azilsartan and Amlodipine Besylate Tablets Matching Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, male or female. 2. Clinically diagnosed with essential hypertension. 3. Patients who have been treated with 5 mg amlodipine besylate tablets alone for at least 4 weeks prior to randomization, and whose blood pressure is still considered inadequately controlled by the investigator. 4. On the day of randomization, before randomization, mean seated office systolic blood pressure (SBP) >=140 mmHg and <180 mmHg, and mean seated office diastolic blood pressure (DBP) <110 mmHg. 5. Female participants of childbearing potential must agree to use effective contraceptive measures during the study period. 6. Voluntarily participate in the study and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension, malignant hypertension, hypertensive emergency, or hypertensive urgency. 2. Patients currently taking aliskiren hemifumarate or expected to require aliskiren hemifumarate during the study period. 3. Patients allergic to the study drugs. 4. Pregnant or suspected pregnant women, as well as breastfeeding women. 5. Patients with bilateral renal artery stenosis or patients with unilateral renal artery stenosis and a single kidney. 6. Patients with hyperkalemia. 7. Patients with severe renal impairment (e.g., eGFR <15 mL/min/1.73 m²). 8. Patients with severe hepatic impairment (e.g., Child-Pugh class C). 9. Patients currently participating in other interventional clinical trials. 10. Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
msSBP;	—

Secondary

Measure	Time frame
msDBP;blood pressure control rate(SBP<140mmHg and DBP<90mmHg);blood pressure response rate(SBP<140mmHg or decrease in SBP=20mmHg);	—

Countries

China

Contacts

Public ContactJiguang Wang

Ruijin Hospital of Shanghai JiaoTong University School of Medicine

jiguangw@163.com+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026