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A multi-center randomized controlled study on the effects of Olmesartan/Amlodipine (Tianshuping) administrated in morning or at nighttime on nocturnal blood pressure control in patients with essential hypertension

A multi-center randomized controlled study on the effects of Olmesartan/Amlodipine (Tianshuping) administrated in morning or at nighttime on nocturnal blood pressure control in patients with essential hypertension

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059719
Enrollment
Unknown
Registered
2022-05-10
Start date
2022-06-01
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Hypertension

Interventions

Group 1 :Taking Olmesartan/Amlodipine (Tianshuping) pill at 06:00-10:00 am everyday
Group 2:Taking Olmesartan/Amlodipine (Tianshuping) pill at 18:00-22:00 pm everyday

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with essential hypertension, age >= 18 years old, gender is not limited, regular schedule activities and work and rest time; 2. Not receiving antihypertensive treatment or stopping antihypertensive drugs for more than 2 week; 3. Sign the informed consent form and be able to participate in follow-up visits on time.

Exclusion criteria

Exclusion criteria: 1. Women who plan to become pregnant or are pregnant or breastfeeding; 2. Bilateral renal artery stenosis; 3. Hyperkalemia (serum potassium > 5.5 mmol/L), chronic renal insufficiency (creatinine > 265 umol/L); 4. Malignant hypertension, hypertensive emergency or sub-emergency, hypertensive crisis and hypertensive encephalopathy, etc.; 5. Have a history of angioedema, drug-related or caused by other reasons; or have a history of allergy to angiotensin receptor antagonists, angiotensin converting enzyme inhibitors or renin inhibitors; 6. Has a history of alcoholism or narcotics addiction; 7. Engaged in night shift or shift work; 8. Cardiovascular disease and certain related diseases, such as unstable angina, heart failure, life-threatening arrhythmia, atrial fibrillation, renal failure, and grade III-IV retinopathy; 9. People with deep dipper blood pressure; 10. Those who cannot tolerate ambulatory blood pressure measurement and other circumstances that cannot participate in clinical research.

Design outcomes

Primary

MeasureTime frame
The reduction of average nocturnal systolic blood pressure;24-h diastolic blood pressure control rate of ambulatory blood pressure measurement at weeks 4;

Secondary

MeasureTime frame
Reduction in nighttime average systolic blood pressure of ambulatory blood pressure measurement at weeks 4;Reduction in 24-h average systolic blood pressure of ambulatory blood pressure measurement at weeks 4;Reduction in 24-h average diastolic blood pressure of ambulatory blood pressure measurement at weeks 4;Reduction in 24-h average systolic blood pressure of ambulatory blood pressure measurement at weeks 12;Reduction in 24-h average diastolic blood pressure of ambulatory blood pressure measurement at weeks 12;Reduction in daytime average systolic blood pressure of ambulatory blood pressure measurement at weeks 4;Reduction in daytime average diastolic blood pressure of ambulatory blood pressure measurement at weeks 4;Reduction in daytime average systolic blood pressure of ambulatory blood pressure measurement at weeks 12;Reduction in daytime average diastolic blood pressure of ambulatory blood pressure measurement at weeks 12;24-h systolic blood pressure control rate of ambulatory blood pressure measurement at weeks 4;24-h systolic blood pressure control rate of ambulatory blood pressure measurement at weeks 12;24-h diastolic blood pressure control rate of ambulatory blood pressure measurement at weeks 12;Daytime systolic blood pressure control rate of ambulatory blood pressure measurement at weeks 4;Daytime systolic blood pressure control rate of ambulatory blood pressure measurement at weeks 12;Daytime diastolic blood pressure control rate of ambulatory blood pressure measurement at weeks 4;Daytime diastolic blood pressure control rate of ambulatory blood pressure measurement at weeks 12;Nighttime systolic blood pressure control rate of ambulatory blood pressure measurement at weeks 4;Nighttime systolic blood pressure control rate of ambulatory blood pressure measurement at weeks 12;Nighttime diastolic blood pressure control rate of ambulatory blood pressure measurement at weeks 4;Nighttime diastolic blood pressure control rate of ambulatory blood pressure meas

Countries

China

Contacts

Public ContactChen Xiaoping

West China Hospital, Sichuan University

Xiaopingchen111@126.com+86 18980601226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026