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Trial record 93 of 134 for:    OLMESARTAN

Azilsartan in Chinese Patients With Mild and Moderate Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609490
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Azilsartan tablets Drug: Azilsartan placebo tablets Drug: Olmesartan medoxomil tablets Drug: olmesartan medoxomil placebo tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment-Azilsartan
Azilsartan tabelts
Drug: Azilsartan tablets
20mg/tablet

Drug: olmesartan medoxomil placebo tablets
placebo tablet

Active Comparator: Positive Control-olmesartan medoxomil
olmesartan medoxomil tablets
Drug: Azilsartan placebo tablets
placebo tablet

Drug: Olmesartan medoxomil tablets
20mg/tablet




Primary Outcome Measures :
  1. Decrease of sitting diastolic blood pressure at week 16 [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-70 years of age (including 18 and 70 years of age), male or female;
  2. diagnosed with mild to moderate essential hypertension;
  3. 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);
  4. understand clearly that voluntary to participate in the study, sign informed consent.

Exclusion Criteria:

  1. severe essential hypertension (sitting systolic ≥180mmHg and / or sitting diastolic pressure ≥110mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy.
  2. secondary hypertension.
  3. 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.
  4. significant laboratory abnormalities include: serum potassium> 5.5mmol / L; blood ALT or AST> 2.5ULN; serum creatinine> 1.5ULN.
  5. unilateral or bilateral renal artery stenosis.
  6. Type 1 diabetes and poor glycemic control of type 2 diabetes (HbA1c values ≥ 8%).
  7. 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.
  8. azilsartan sheet or olmesartan medoxomil tablets and related drugs (ARB, ACEI And renin inhibitors) allergies.
  9. pregnant, lactating female patients, or during the test does not guarantee the effective collision pregnant person.
  10. Obesity, body mass index (BMI)> 30kg / m2.
  11. 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.
  12. Variance of diastolic blood pressure ≥8mmHg.
  13. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609490


Locations
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China
Peking University First hospiatl
Beijing, China, 100000
Sponsors and Collaborators
Lee's Pharmaceutical Limited

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT02609490     History of Changes
Other Study ID Numbers: Zhaoke-201505-Azilsartan
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan Medoxomil
Azilsartan medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action