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A Placebo Controlled Phase II Trial of Allisartan

A Randomized, Double Blind, Placebo-Controlled, Multicenter Trial of Allisartan Isoproxil for treatment of Essential Hypertensive Population at Low-Medium Risk

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000886
Enrollment
Unknown
Registered
2010-05-28
Start date
2009-07-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

essential hypertension at low-medium risk

Interventions

Group B:Placebo, orally taken once daily for 8 weeks
Group A:Allisartan 240mg, orally taken once daily for 8 we

Sponsors

The Third Xiangya Hospital of Centre-south University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 70 years old; 2. 18.5kg/m2 <= BMI <= 26kg/m2 (BMI= body weight/height2); 3. Mild to moderate essential hypertension according to the diagnostic criteria of China (2005); 4. The mean seated blood pressure after 2-week washout period with placebo (the blood pressure should be detected 3 times every 2 minutes after 5-minute resting in sitting position and then take the mean value) should be 140mmHg <= SBP<180mmHg and 90mmHg <= DBP< 110mmHg; 5. Able and willing to provide signed consent.

Exclusion criteria

Exclusion criteria: 1. Having been diagnosed or suspected as secondary hypertension; 2. Difference of SeSBP>20mmHg or Difference of SeDBP>10mmHg ad tres vices when determined; 3. Sick sinus syndrome, II~III atrial ventricular block, atrial flutter, atrial fibrillation, or other malignant arrhythmia; 4. Aneurysm in conducting artery or dissecting aneurysm, percutaneous tranluminal coronary angioplasty (PTCA) or other cardiac surgery; 5. Unstable angina pectoris, acute myocardial infarction, cardiac failure, and cerebral accidents within recent 6 months; 6. Asthma or moderate to severe chronic obstructive lung disease; 7. Uncontrolled diabetes, FBG >=11mmol/L or with complications (degenerative nephritis and peripheral neuropathy); 8. Renal arterial stenosis; 9. Renal inadequacy ( Cr>1.5*ULN (the upper limit of the normal range)); 10. Serious hepatopathy or hepatic inadequacy (ALT, AST or TBIL> 2*ULN); 11. Electrolyte disturbances (blood potassium or sodium abnormality); 12. Subjects with lower blood volume; 13. Female subjects with pregnancy or in lactation; 14. Subjects with drug or alcohol dependence; 15. Concomitant treatment with other drugs which will affect the blood pressure; 16. Subjects with resistant hypertension; 17. History of drug allergy or known allergy to ARB drugs; 18. Having participated in other drug's clinical study within recent 3 months; 19. Suspected as white overcoat hypertension according to the judgement of investigators; 20. Subjects are thought unsuitable for the study by investigators.

Design outcomes

Primary

MeasureTime frame
The change value of seated diastolic blood pressure;

Secondary

MeasureTime frame
The effective power of subjects after 4 and 8 week;The change value of seated systolic blood pressure;The change value of seated blood pressure at Week 4 and week 8;The change value of seated systolic blood pressure at Weeks 4 and Week 8 compared to baseline;The effective power of subjects after 4 and 8 weeks' treatment;

Countries

China

Contacts

Public ContactHong Yuan
yuanhong@vip.sina.com+86 731 8618339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026