Clinical trial NCT02609490: Azilsartan in Chinese Patients With Mild and Moderate Hypertension
Official title: A Multi-center, Randomized, Double-blind, Double-dummy, With Olmesartan Medoxomil as Positive Control Parallel Clinical Study to Evaluate the the Safety and Efficacy of Azilsartan in Chinese Patients With Primary Mild and Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients


Eligibility criteria: Inclusion Criteria:

1. 18-70 years of age (including 18 and 70 years of age), male or female;
2. diagnosed with mild to moderate essential hypertension;
3. clinic diastolic and systolic blood pressure need to meet the following two conditions: 3 times mean sitting diastolic blood pressure measurements at 95mmHg-110mmHg (not including 110mmHg); 3 times sitting systolic blood pressure measured and mean value between150mmHg-180mmHg (not including 180mmHg);
4. understand clearly that voluntary to participate in the study, sign informed consent.

Exclusion Criteria:

1. severe essential hypertension (sitting systolic ≥180mmHg and / or sitting diastolic pressure ≥110mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy.
2. secondary hypertension.
3. The following hypertension and diseases: acute myocardial infarction within 6 months, the cerebral artery accident, transient ischemic attack; or dissecting aortic aneurysm, angina, II-IVClass (NYHA classification) history of heart failure Ⅱ degree atrioventricular block, sick sinus integrated disease, bradycardia (heart rate \<50 beats / min) or other antiarrhythmic drugs needed.
4. significant laboratory abnormalities include: serum potassium\> 5.5mmol / L; blood ALT or AST\> 2.5ULN; serum creatinine\> 1.5ULN.
5. unilateral or bilateral renal artery stenosis.
6. Type 1 diabetes and poor glycemic control of type 2 diabetes (HbA1c values ≥ 8%).
7. gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as stomach-bowel resection, nearly one year activity of gastrointestinal inflammation, ulcers or gastrointestinal bleeding.
8. azilsartan sheet or olmesartan medoxomil tablets and related drugs (ARB, ACEI And renin inhibitors) allergies.
9. pregnant, lactating female patients, or during the test does not guarantee the effective collision pregnant person.
10. Obesity, body mass index (BMI)\> 30kg / m2.
11. Import of use in addition to import other types of medication trials of antihypertensive drugs, Anti-angina drugs, lithium agents, corticosteroids, licorice, estrogen, digitalis Drugs and drugs were potassium.
12. Variance of diastolic blood pressure ≥8mmHg.
13. drug or alcohol abuse within 6 months Are drinking more than two units of alcohol (1 unit = 360mL or 45mL alcohol content of 40%).

14 patients with malignant tumors. 15. hemodialysis patients or strictly limit salt therapy. 16. Participated in other clinical trials within 30 days.

Primary outcomes:
measure: Decrease of sitting diastolic blood pressure at week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Decrease of sitting diastolic blood pressure at week 8
timeFrame: 8 weeks
measure: Decrease of sitting systolic blood pressure at week 8
timeFrame: 8 weeks
measure: Decrease of sitting diastolic blood pressure at week 2
timeFrame: 2 weeks
measure: Decrease of sitting diastolic blood pressure at week 4
timeFrame: 4 weeks
measure: Decrease of sitting diastolic blood pressure at week 12
timeFrame: 12weeks
measure: Decrease of sitting systolic blood pressure at week 2
timeFrame: 2 weeks
measure: Decrease of sitting systolic blood pressure at week 4
timeFrame: 4 weeks
measure: Decrease of sitting systolic blood pressure at week 12
timeFrame: 12 weeks
measure: decrease of 24-hour ambulatory blood pressure monitoring at week 16
timeFrame: 16 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First hospiatl
Study officials:
References: