CompletedPhase 3

Azilsartan in Chinese Patients With Mild and Moderate Hypertension

China304 participantsStarted 2015-09

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 18-70 years of age (including 18 and 70 years of age), male or female;
✓. diagnosed with mild to moderate essential hypertension;
✓. 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);
✓. understand clearly that voluntary to participate in the study, sign informed consent.

✕. severe essential hypertension (sitting systolic ≥180mmHg and / or sitting diastolic pressure ≥110mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy.
✕. secondary hypertension.
✕. 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.
✕. significant laboratory abnormalities include: serum potassium\> 5.5mmol / L; blood ALT or AST\> 2.5ULN; serum creatinine\> 1.5ULN.
✕. unilateral or bilateral renal artery stenosis.
✕. Type 1 diabetes and poor glycemic control of type 2 diabetes (HbA1c values ≥ 8%).
✕. 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.
✕. azilsartan sheet or olmesartan medoxomil tablets and related drugs (ARB, ACEI And renin inhibitors) allergies.

Decrease of sitting diastolic blood pressure at week 16

Timeframe: 16 weeks

NCT IDNCT02609490

SponsorLee's Pharmaceutical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 18-70 years of age (including 18 and 70 years of age), male or female;
✓. diagnosed with mild to moderate essential hypertension;
✓. 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);
✓. understand clearly that voluntary to participate in the study, sign informed consent.

✕. severe essential hypertension (sitting systolic ≥180mmHg and / or sitting diastolic pressure ≥110mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy.
✕. secondary hypertension.
✕. 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.
✕. significant laboratory abnormalities include: serum potassium\> 5.5mmol / L; blood ALT or AST\> 2.5ULN; serum creatinine\> 1.5ULN.
✕. unilateral or bilateral renal artery stenosis.
✕. Type 1 diabetes and poor glycemic control of type 2 diabetes (HbA1c values ≥ 8%).
✕. 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.
✕. azilsartan sheet or olmesartan medoxomil tablets and related drugs (ARB, ACEI And renin inhibitors) allergies.