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The efficacy of Chinese traditional single pill containing quadruple combination of blood pressure medicines versus valsartan/hydrochlorothiazide in patients with hypertension: a multicenter, open-label, non-inferiority, randomized controlled study

The efficacy of Chinese traditional single pill containing quadruple combination of blood pressure medicines versus valsartan/hydrochlorothiazide in patients with hypertension: a multicenter, open-label, non-inferiority, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067920
Enrollment
Unknown
Registered
2023-01-31
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Hypertension

Interventions

Group 1:take compound reserpine and triamterene tablets
Group 2:take valsartan/hydrochlorothiazide

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with hypertension, aged 18-80 years old, regardless of gender; 2. Untreated patients, or patients who have stopped taking antihypertensive drugs for 2 weeks, can satisfy either A or B: A. Office blood pressure: systolic blood pressure 140-179 mmHg and/or diastolic blood pressure 90-109 mmHg; B. 24h ambulatory blood pressure monitoring: mean 24h blood pressure>=130/80 mmHg, and/or mean daytime blood pressure>=135/85 mmHg, and/or mean nighttime blood pressure>=120/70 mmHg.

Exclusion criteria

Exclusion criteria: 1. Planned pregnancy, pregnancy and lactation women; 2. Bilateral renal artery stenosis; 3. Hyperkalemia (blood potassium>5.5mmol/L), renal insufficiency (creatinine>265umol/L, eGFR < 30ml/(min · 1.73m^2)) 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 alcoholism or narcotic addiction; 7. Cardiovascular diseases and some related diseases, such as unstable angina pectoris, heart failure, life-threatening arrhythmia Atrial fibrillation, renal failure and grade III-IV retinopathy; 8. History of depression or other mental diseases; 9. Patients with active gastrointestinal ulcer and ulcerative colitis; 10. Inability to tolerate ambulatory blood pressure measurement and other situations that cannot participate in clinical research.

Design outcomes

Primary

MeasureTime frame
mean 24h systolic blood pressure reduction;

Secondary

MeasureTime frame
mean change from baseline in office systolic blood pressure;mean change from baseline in office diastolic blood pressure;mean 24h diastolic blood pressure reduction;mean daytime systolic blood pressure reduction;mean daytime diastolic blood pressure reduction;mean nighttime systolic blood pressure reduction;mean nighttime diastolic blood pressure reduction;changes of blood lipids;changes of blood glucose;changes of blood uric acid;changes of electrolyte;incidence rate of adverse events in two groups;Anxiety and depression before and after treatment;Incidence rate of adverse events;

Countries

China

Contacts

Public ContactXiaoping Chen

West China Hospital of Sichuan University

chenxp13@aliyun.com+86 18980601226

Outcome results

None listed

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