Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension

NCT ID: NCT02407210

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

Brief Summary

To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

azilsartan group

Once-daily oral administration of 20 or 40 mg tablet before or after breakfast

Group Type: EXPERIMENTAL

azilsartan

Intervention Type: DRUG

olmesartan medoxomil group

Once-daily oral administration of 20 or 40 mg tablet before or after breakfast

Group Type: ACTIVE_COMPARATOR

Olmesartan medoxomil

Intervention Type: DRUG

Interventions

azilsartan

Intervention Type: DRUG

Olmesartan medoxomil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Both sexes. eighteen years or older and no more than 70 years at the time of informed consent

2. Grade I or II essential hypertension

3. Both sitting systolic and diastolic blood pressures at Week 0 during the run-in period meet the following criteria:

Sitting systolic blood pressure: greater than or equal to 150 mmHg and less than 180 mmHg

Sitting diastolic blood pressure: greater than or equal to 95 mmHg and less than 110 mmHg

4. Able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study

Exclusion Criteria

1. Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), or malignant hypertension，hypertensive emergencies，hypertensive urgencies

2. The following circulatory-related diseases or symptoms:

(1) Cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia； (2) Cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period)； (3) Vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication； (4) Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)

3. Decrease in sitting diastolic blood pressure by 8 mmHg or more at the end of the run-in period (Week 0) compared to the start of the screening period

4. Day/night reversal, e.g., nightshift worker

5. Unilateral or bilateral renal artery stenosis

6. Clinically apparent hepatic and renal impairment (e.g., with AST and ALT values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)

7. Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the run-in period)

8. Malignant tumor

9. Compliance with the study drug of less than 80% during the run-in period

10. Poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/L)，and/or complications (kidney disease, peripheral neuropathy) at Screening.

11. History of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (ARB, ACE inhibitors, and renin inhibitors)

12. History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period

13. Requirement of the excluded treatment

14. Pregnant or lactating women

15. Participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period

16. Dangerous machinery operator such as aerial worker，motor vehicle driver

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing ANZHEN Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Changsheng Ma, Professor

Role: primary

chshma@vip.sina.com

86-010-64456078

Other Identifiers

HR-AQST-2014

Identifier Type: -

Identifier Source: org_study_id