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A Multiple-dose, Positive Controlled Phase II Trial of Allisartan

A Randomized, Double-Blind and Double-Dummy, Multiple-dose, Multicenter, Positive Controlled, Parallel, Phase II Trial of Allisartan Isoproxil in Patients with Mild to Moderate Essential Hypertension

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000884
Enrollment
Unknown
Registered
2010-05-28
Start date
2008-08-01
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 A:Allisartan 80mg, orally taken once daily for 8 weeks
Group B:Allisartan 160mg, orally taken once daily for 8 week
Group C:Allisartan 240mg, orally taken once daily for 8 weeks
Group D:losartan 50mg, orally taken once daily for 8 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. 18.5kg/m2 <= BMI <= 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. To be able to and willing to provide signed consent.

Exclusion criteria

Exclusion criteria: 1. Having been diagnosed or suspected as secondary hypertension; 2. Differece 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. History of drug allergy or known allergy to ARB drugs; 17. Having participated in other drug's clinical study within recent 3 months; 18. Suspected as white overcoat hypertension according to the judgement of investigators; 19. Subjects are thought unsuitable for the study by investigators.

Design outcomes

Primary

MeasureTime frame
the change value of seated blood pressure at Weeks 8 compared to baseline;

Secondary

MeasureTime frame
the change value of seated blood pressure at Weeks 4 compared to baseline;the change value of seated blood pressure at Week 4 and Week 8 compared to baseline in subjects wh;the percentage of subjects whose seated blood pressure is normalized at Week 4 and Week 8;

Countries

China

Contacts

Public ContactNinglin Sun

Peking University People's Hospital

nlsun@263.net+86 10 88325554

Outcome results

None listed

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