Mild to moderate essential hypertension
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| The change value of seated diastolic blood pressure; | — |
Secondary
| Measure | Time 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