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

NCT02407210 | Unknown Phase 3

• 1 other identifier: HR-AQST-2014
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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

Keywords

Azilsartan，Olmesartan Medoxomil

Outcome Measures

Primary Outcomes (1)

• Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period)

  16 weeks

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

azilsartan group

EXPERIMENTAL

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

Drug: azilsartan

olmesartan medoxomil group

ACTIVE COMPARATOR

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

Drug: Olmesartan medoxomil

Interventions

azilsartan DRUG

azilsartan group

Olmesartan medoxomil DRUG

olmesartan medoxomil group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing ANZHEN Hospital

Beijing, 100029, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Interventions

azilsartan; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Last Updated: April 2, 2015

Record last verified: 2015-01

Locations

CN (1)