Azilsartan in Chinese Patients With Mild and Moderate Hypertension

NCT02609490 | Completed Phase 3

• 1 other identifier: Zhaoke-201505-Azilsartan
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Decrease of sitting diastolic blood pressure at week 16

  16 weeks

Secondary Outcomes (9)

• 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

Study Arms (2)

Treatment-Azilsartan

EXPERIMENTAL

Azilsartan tabelts

Drug: Azilsartan tablets; Drug: olmesartan medoxomil placebo tablets

Positive Control-olmesartan medoxomil

ACTIVE COMPARATOR

olmesartan medoxomil tablets

Drug: Azilsartan placebo tablets; Drug: Olmesartan medoxomil tablets

Interventions

Azilsartan tablets DRUG

20mg/tablet

Treatment-Azilsartan

Azilsartan placebo tablets DRUG

placebo tablet

Positive Control-olmesartan medoxomil

Olmesartan medoxomil tablets DRUG

20mg/tablet

Positive Control-olmesartan medoxomil

olmesartan medoxomil placebo tablets DRUG

placebo tablet

Treatment-Azilsartan

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• pregnant, lactating female patients, or during the test does not guarantee the effective collision pregnant person.
• Obesity, body mass index (BMI)\> 30kg / m2.
• 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.
• Variance of diastolic blood pressure ≥8mmHg.
• drug or alcohol abuse within 6 months Are drinking more than two units of alcohol (1 unit = 360mL or 45mL alcohol content of 40%).
• patients with malignant tumors. 15. hemodialysis patients or strictly limit salt therapy. 16. Participated in other clinical trials within 30 days.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Peking University First hospiatl

Beijing, 100000, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

azilsartan; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

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: November 17, 2015
• First Posted: November 20, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

CN (1)