Hypertension
Conditions
Interventions
Treatment group:All eligible subjects will receive OLM 20mg/d additionally on the treatment of AML 5mg/d to lower the blood pressure at least for 8 weeks. If target blood pressure (SeDBP<90mmHg, SeDBP
Sponsors
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Outpatients with mild or moderate essential hypertension who also satisfy the following main criteria: 1. Male or female, 18 to 75 years of age (including 18 and 75 years of age); 2. Treated with AML 5mg/d for more than 4 weeks but failed in reaching the treatment goal: SeDBP =80 mmHg for DM subjects), and Mean SeSBP < 180 mmHg; 4. The subject is willing and able to adhere to take the study drugs as prescribed, and meets other requirements of the trial; 5. The subject can sign the informed consent for participating in this study.
Exclusion criteria
Exclusion criteria: The subject who has any one of the following can not be enrolled into this study: 1. Subject with secondary hypertension; 2. Insulin dependent diabetes mellitus; 3. Uncontrolled non-insulin dependent diabetes mellitus (fasting blood glucose > 200 mg/dl or 11.1 mmol/L, concomitant with diabetic peripheral neuropathy or automatic neuropathy); 4. Subject with unstable condition for disease of myocardial infarction, clinically decompensated congestive heart failure, angina pectoris, sick sinus syndrome, second or third degree atrioventricular block; 5. Having cerebrovascular accident in three month before the enrollment; 6. Severe liver function impairment and renal function impairment: ALT(GPT), AST(GOT) 2 times of up limit of normal range, Cr 1.5 times of up limit of normal range, proteinuria 2+; 7. Subject with hypokalemia, K+<3.5mmol/L; 8. Autoimmune diseases(SLE); 9. Subject with malignant disease within 5 years except carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer; 10. Subject with substance abuse history; 11. Medical necessary of using other medication which might impact the blood pressure of the patients, except amlodipine; 12. Women being pregnant or lactating, or women of child-bearing potential but unable or unwilling to take a highly effective method of contraception; 13. Subject with any other serious disease considered by the investigator not in the condition to enter the trial; 14. Subject not able to comply with the protocol requirements; 15. Subject participated in investigational drug trial within 4 weeks before entering into this study; 16. Subject allergic to the investigational drug or component of the investigational drug(such as: dihydropyridine CCB, thiazides, Sulfonamide-derive drugs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the responder rate in the treatment groups at Visit 4 (16th week); | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean change of trough SeDBP and SeSBP from the baseline at visit 2(week 4), 3 (week 8), 5(week 12), (week 16);The achieve goal rate at visit 2(4th week), 3 (8th week), 5(12th week), 6 (16th week).; | — |
Countries
China
Contacts
Public ContactGAO Ping-jin
Shanghai JiaoTong University School of Medicine, Ruijing Hospital
Outcome results
None listed