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Efficacy and safety of azilsartan in mild-to-moderate non-dipper essential hypertension: a randomized controlled open-label study

Efficacy and safety of azilsartan in mild-to-moderate non-dipper essential hypertension: a randomized controlled open-label study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073616
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-07-17
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

hypertension

Interventions

Group of azilsartan:azilsartan treatment
Group of Valsartan: Valsartan treatment

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.1 Male or female patients aged 18-75; 1.2 Meet the diagnostic criteria for mild to moderate essential hypertension (the average DBP of 3 sitting positions is =95mmHg (1mmHg=0.1333kPa), and <110mmHg; and the average value of SBP of 3 sitting positions is <180mmHg); 1.3 Screen patients with non-dipper blood pressure rhythm through 24-hour ambulatory blood pressure monitoring (24hABPM); 1.4 Subjects or their guardians agree to participate in this study.

Exclusion criteria

Exclusion criteria: 2.1 Secondary hypertension; 2.2 Intolerance of ACEI, ARB or CCB drug therapy in the past, or taking experimental drugs; 2.3 Severe liver or kidney disease (ALT=3 times the upper limit of normal; eGFR35% when screening to randomization); 2.4 Serum potassium>5.2mmol/L at screening, or blood potassium>5.4mmol/L at the end of the lead-in period; 2.5 Symptomatic hypotension, SBP 8%); 2.10 Takayasu arteritis, Kawasaki disease, coronary artery malformation; 2.11 Those who are pregnant or breastfeeding, or who intend to give birth within one year; 2.12 Other clinically significant diseases such as stroke, hemorrhage, and malignant tumors may cause serious danger to patients; 2.13 Patients who participated in clinical research of other drugs within 3 months before enrollment; 2.14 The investigator judges that the patient has any conditions that are not suitable for participating in this study

Design outcomes

Primary

MeasureTime frame
ambulatory blood pressure;

Secondary

MeasureTime frame
Echocardiography;blood routine;urine routine;Blood chemistry;liver function;kidney function;Glycated hemoglobin;blood lipid;

Countries

China

Contacts

Public ContactTi Yun

Qilu Hospital of Shandong University

781900466@qq.com+86 185 6008 6595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026