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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02407210

Collaborator

(none)

304

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: azilsartan Drug: Olmesartan medoxomil	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

304 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: azilsartan group Once-daily oral administration of 20 or 40 mg tablet before or after breakfast	Drug: azilsartan
Active Comparator: olmesartan medoxomil group Once-daily oral administration of 20 or 40 mg tablet before or after breakfast	Drug: Olmesartan medoxomil

Arm

Intervention/Treatment

Experimental: azilsartan group

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

Drug: azilsartan

Active Comparator: olmesartan medoxomil group

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

Drug: Olmesartan medoxomil

Outcome Measures

Primary Outcome Measures

Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period) [16 weeks]

Secondary Outcome Measures

Trough sitting systolic blood pressure (change from end of the run-in period to end of the treatment period) [16 weeks]
Trough sitting diastolic and systolic blood pressure (change from end of the run-in period to Week 8 of the treatment period) [8 weeks]
Trough sitting diastolic and systolic blood pressures at each evaluation [2 weeks]
responder rate; rate of patients with normalized blood pressure [8 weeks and 16 weeks]
Responder is defined as a ≥20mmHg decrease in sitting trough SBP and a ≥10mmHg decrease in sitting trough DBP，or a sitting trough SBP of <140mmHg and a sitting trough DBP of <90mmHg；normalized blood pressure is defined as a sitting trough SBP of <140mmHg and a sitting trough DBP of <90mmHg.
evaluation by ABPM (1: 24-hour mean change in diastolic and systolic blood pressures, 2: Trough/Peak ratio of diastolic and systolic blood pressures)(change from end of the run-in period to Week 14 of the treatment period) [14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both sexes. eighteen years or older and no more than 70 years at the time of informed consent
Grade I or II essential hypertension
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

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:

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
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)

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
Day/night reversal, e.g., nightshift worker
Unilateral or bilateral renal artery stenosis
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)
Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the run-in period)
Malignant tumor
Compliance with the study drug of less than 80% during the run-in period
Poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/L)，and/or complications (kidney disease, peripheral neuropathy) at Screening.
History of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (ARB, ACE inhibitors, and renin inhibitors)
History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
Requirement of the excluded treatment
Pregnant or lactating women
Participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
Dangerous machinery operator such as aerial worker，motor vehicle driver