Azilsartan in Chinese Patients With Mild and Moderate Hypertension

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Azilsartan tablets; Drug: olmesartan medoxomil placebo tablets; Drug: Azilsartan placebo tablets; Drug: Olmesartan medoxomil tablets

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100000
    • Peking University First hospiatl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment-Azilsartan; Azilsartan tabelts	Drug: Azilsartan tablets; 20mg/tablet; Drug: olmesartan medoxomil placebo tablets; placebo tablet
Active Comparator: Positive Control-olmesartan medoxomil; olmesartan medoxomil tablets	Drug: Azilsartan placebo tablets; placebo tablet; Drug: Olmesartan medoxomil tablets; 20mg/tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease of sitting diastolic blood pressure at week 16	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease of sitting diastolic blood pressure at week 8		8 weeks
Decrease of sitting systolic blood pressure at week 8		8 weeks
Decrease of sitting diastolic blood pressure at week 2		2 weeks
Decrease of sitting diastolic blood pressure at week 4		4 weeks
Decrease of sitting diastolic blood pressure at week 12		12weeks
Decrease of sitting systolic blood pressure at week 2		2 weeks
Decrease of sitting systolic blood pressure at week 4		4 weeks
Decrease of sitting systolic blood pressure at week 12		12 weeks
decrease of 24-hour ambulatory blood pressure monitoring at week 16	do a 24-hour ambulatory blood pressure monitoring at baseline and at week 16, compare the decrease.	16 week

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan; Olmesartan Medoxomil; Azilsartan medoxomil
• Other Study ID Numbers: Zhaoke-201505-Azilsartan