ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential 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: NCT02407210
Recruitment Status : Unknown
Verified January 2015 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2015
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Trough sitting systolic blood pressure (change from end of the run-in period to end of the treatment period) [ Time Frame: 16 weeks ]
  2. Trough sitting diastolic and systolic blood pressure (change from end of the run-in period to Week 8 of the treatment period) [ Time Frame: 8 weeks ]
  3. Trough sitting diastolic and systolic blood pressures at each evaluation [ Time Frame: 2 weeks ]
  4. responder rate; rate of patients with normalized blood pressure [ Time Frame: 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.

  5. 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) [ Time Frame: 14 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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. Both sexes. eighteen years or older and no more than 70 years at the time of informed consent
  2. Grade I or II essential hypertension
  3. 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

  4. 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:

  1. 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
  2. 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)

3. 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

4. Day/night reversal, e.g., nightshift worker

5. Unilateral or bilateral renal artery stenosis

6. 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)

7. Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the run-in period)

8. Malignant tumor

9. Compliance with the study drug of less than 80% during the run-in period

10. Poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/L),and/or complications (kidney disease, peripheral neuropathy) at Screening.

11. History of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (ARB, ACE inhibitors, and renin inhibitors)

12. History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period

13. Requirement of the excluded treatment

14. Pregnant or lactating women

15. Participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period

16. Dangerous machinery operator such as aerial worker,motor vehicle driver


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): NCT02407210


Locations
China
Beijing ANZHEN Hospital Recruiting
Beijing, China, 100029
Contact: Changsheng Ma, Professor    86-010-64456078    chshma@vip.sina.com   
Principal Investigator: Changsheng Ma, Professor         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02407210     History of Changes
Other Study ID Numbers: HR-AQST-2014
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: January 2015

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Azilsartan,Olmesartan Medoxomil

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action