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Completed

NCT Number: NCT02609490

Azilsartan in Chinese Patients With Mild and Moderate Hypertension

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First hospiatl

Beijing, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-70 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.

Exclusion criteria

  • 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%).

14 patients with malignant tumors. 15. hemodialysis patients or strictly limit salt therapy. 16. Participated in other clinical trials within 30 days.

Treatment and study plan

Azilsartan tablets

Drug

20mg/tablet

Azilsartan placebo tablets

Drug

placebo tablet

Olmesartan medoxomil tablets

Drug

20mg/tablet

olmesartan medoxomil placebo tablets

Drug

placebo tablet

Primary outcomes

  1. Decrease of sitting diastolic blood pressure at week 16

    Time frame: 16 weeks

Secondary outcomes

  1. Decrease of sitting diastolic blood pressure at week 8

    Time frame: 8 weeks

  2. Decrease of sitting systolic blood pressure at week 8

    Time frame: 8 weeks

  3. Decrease of sitting diastolic blood pressure at week 2

    Time frame: 2 weeks

  4. Decrease of sitting diastolic blood pressure at week 4

    Time frame: 4 weeks

  5. Decrease of sitting diastolic blood pressure at week 12

    Time frame: 12weeks

  6. Decrease of sitting systolic blood pressure at week 2

    Time frame: 2 weeks

  7. Decrease of sitting systolic blood pressure at week 4

    Time frame: 4 weeks

  8. Decrease of sitting systolic blood pressure at week 12

    Time frame: 12 weeks

  9. decrease of 24-hour ambulatory blood pressure monitoring at week 16

    Time frame: 16 week

    do a 24-hour ambulatory blood pressure monitoring at baseline and at week 16, compare the decrease.

Sponsors and collaborators

Lead sponsor

Lee's Pharmaceutical Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 20, 2015
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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