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A Positive Controlled Phase III Trial of Allisartan

A Randomized, Double Blind, Multicenter, Parallel Controlled, Phase III Trial to compare the effect and safety of Allisartan Isoproxil 240mg and losartan potassium 50mg in Patients with hypertension

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000885
Enrollment
Unknown
Registered
2010-05-28
Start date
2009-06-01
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

Mild to moderate essential hypertension

Interventions

Group B:losartan 50mg, orally taken once daily for 12 week
Group A:Allisartan 240mg, orally taken once daily for 12 weeks

Sponsors

Peking University People's Hospital
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. BMI between 18.5kg/m2 and 30kg/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
TThe change value of 24h mean ambulatory blood pressure at Weeks 12 compared to baseline;The effective power of subjects after 4, 8 and 12;The change value of seated diastolic blood pressure at Weeks 4 and Week 8 compared to baseline;Trough/peak ratio;The change value of mean daytime ambulatory blood pressure and mean night-time ambulatory blood pressure;The change value of seated blood pressure at Week 4, Week 8 and Week 12 compared to baseline in subject;The change value of seated blood pressure at Week 4, Week 8 and Week 12 compared to baseline in sub;The percentage of subjects whose seated blood pressure is normalized at Week 4, Week 8 and Week 12;

Countries

China

Contacts

Public ContactNinglin Sun
nlsun@263.net+86 10 88325554

Outcome results

None listed

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