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Study on the Safety and Efficacy of Aliskiren/Amlodipine Tablets in Patients with Primary Hypertension

Study on the Safety and Efficacy of Aliskiren/Amlodipine Tablets in Patients with Primary Hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103221
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Primary Hypertension

Interventions

Experimental group:Each patient will orally take one tablet of Azilsartan / Amlodipine (240mg Azilsartan + 5mg Amlodipine) daily for 12 consecutive weeks.

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Be between the ages of 18 and 75, regardless of gender. 2. Has been diagnosed with essential hypertension with SBP >=140 mmHg, or DBP>=90 mmHg at baseline in a sitting position. 3. Previous treatment with other antihypertensive drugs with poor or unstable blood pressure control. 4. Signed informed consent and willing to comply with the trial protocol, able to accept follow-up and examination on time. 5. No serious organ function impairment or other diseases that may affect the test results.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to alisartan cilexetil, amlodipine or other ingredients. 2. Pregnant and lactating women or women planning to become pregnant. 3. Patients with severe cardiovascular and cerebrovascular events (such as myocardial infarction, stroke) or severe heart diseases such as unstable angina pectoris and heart failure in the past 6 months. 4. Patients with severe hepatic or renal insufficiency. 5. Patients who are using drugs (such as corticosteroids, immunosuppressants) that may affect blood pressure or interfere with the efficacy of the trial drug, and cannot be discontinued. 6. Patients with a history of severe mental illness or who are receiving relevant treatment. 7. In the opinion of the investigator, it is impossible to complete the entire trial process or other conditions that may affect the results of the trial.

Design outcomes

Primary

MeasureTime frame
Mean systolic and mean diastolic blood pressure in a quiet sitting position;Changes in blood pressure during the day, night, and early morning under 24-hour ambulatory blood pressure monitoring;

Secondary

MeasureTime frame
Blood pressure rebound during the drug-washout period;Changes in uric acid levels;Incidence of adverse reactions during drug treatment and washout period;

Countries

China

Contacts

Public ContactZhou Xin

Tianjin Medical University General Hospital

xinzhou@tmu.edu.cn+86 186 2257 5041

Outcome results

None listed

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