Study on the antihypertensive efficacy of the Compound Hypotensive Tablets in patients with resistant hypertension

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400081878

Enrollment

Unknown

Registered

2024-03-14

Start date

2024-03-15

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

resistant hypertension

Interventions

Intervention group:ACEI/ARB + CCB + Compound Hypotensive Tablets

Control group:ACEI/ARB + CCB + Diuretic + spironolactone

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with essential hypertension, aged 18-75 years; (2) Patients with resistant hypertension, that is, after using sufficient amounts of ACE inhibitors/ARB + calcium channel blockers + diuretics, the blood pressure does not meet the target A or B: A. Clinic blood pressure: systolic blood pressure 140-179mmHg and/or diastolic blood pressure 90-109mmHg; B. 24-hour ambulatory blood pressure monitoring: = 130/80 mmHg throughout the day, and/or 135/85 mmHg = daytime, and/or 120/70 mmHg = night (3) The patient can understand the relevant requirements of the study and cooperate with the study intervention

Exclusion criteria

Exclusion criteria: (1) Women who plan to become pregnant, pregnant, or lactating; (2) secondary hypertension; (3) Patients with double renal artery stenosis, hyperkalemia (serum potassium > 5.5mmol/L), renal insufficiency (creatinine >265umol/L, effective glomerular filtration rate <30ml/(min·1.73m2)); (4) Malignant hypertension, hypertensive emergency, hypertensive crisis and hypertensive encephalopathy; (5) Those who have a history of allergy to the study drug or its components; (6) Have a history of alcohol intoxication or narcotic addiction; (7) Cardiovascular diseases and some related diseases, such as unstable angina, heart failure, life-threatening arrhythmia, atrial fibrillation, renal failure and grade III-IV retinopathy; (8) History of depression or other psychiatric illness; (9) Patients with active peptic ulcer and ulcerative colitis; (10) Long-term oral administration of glucocorticoids, non-steroidal anti-inflammatory drugs, immunosuppressants and other drugs that affect blood pressure (11) Inability to tolerate ambulatory blood pressure measurement and other circumstances that prevent them from participating in clinical studies

Design outcomes

Primary

Measure	Time frame
24-hour mean ambulatory systolic blood pressure;	—

Secondary

Measure	Time frame
asleep SBP/DBP;awake SBP/DBP ;lipids;blood glucose;blood electrolytes;anxiety/depression volume;Incidence rate of adverse events;office blood pressure;	—

Countries

China

Contacts

Public Contactchen xiaoping

West China Hospital, Sichuan University

chenxp13@aliyun.com+86 189 8060 1226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026