Essential HypertensionPhase 3NCT02407210
Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension
A Phase 3 study testing azilsartan and Olmesartan medoxomil in people with Essential Hypertension, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- azilsartan and Olmesartan medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing ANZHEN Hospital
Beijing, 100029
Changsheng Ma, Professor, 86-010-64456078, chshma@vip.sina.com
Changsheng Ma, Professor
About this study
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
To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension
- Conditions
- Essential Hypertension
- Being tested
- azilsartan, Olmesartan medoxomil
- Keywords
- Azilsartan，Olmesartan Medoxomil
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azilsartanDrug
Olmesartan medoxomilDrug
| Study group | Role | What they receive |
|---|---|---|
| azilsartan group | Experimental | Once-daily oral administration of 20 or 40 mg tablet before or after breakfast Receives: Drug: azilsartan |
| olmesartan medoxomil group | Active comparator | Once-daily oral administration of 20 or 40 mg tablet before or after breakfast Receives: Drug: Olmesartan medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period)
Measured: 16 weeks
Secondary outcomes (5)
Trough sitting systolic blood pressure (change from end of the run-in period to end of the treatment period)
Measured: 16 weeks
Trough sitting diastolic and systolic blood pressure (change from end of the run-in period to Week 8 of the treatment period)
Measured: 8 weeks
Trough sitting diastolic and systolic blood pressures at each evaluation
Measured: 2 weeks
responder rate; rate of patients with normalized blood pressure
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.
Measured: 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)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407210
- Sponsor's protocol ID
- HR-AQST-2014
- Status last verified
- Jan 2015
- First submitted
- 30 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02407210
- Acronym / sponsor ID
- HR-AQST-2014
- Conditions
- Essential Hypertension
- Keywords
- Azilsartan，Olmesartan Medoxomil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azilsartan group | Experimental | Drug: azilsartanOnce-daily oral administration of 20 or 40 mg tablet before or after breakfast |
| olmesartan medoxomil group | Active comparator | Drug: Olmesartan medoxomilOnce-daily oral administration of 20 or 40 mg tablet before or after breakfast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azilsartan | Drug | azilsartan group |
| Olmesartan medoxomil | Drug | olmesartan medoxomil group |
Primary outcome
Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period)
Time frame: 16 weeks
5 secondary outcomes
Trough sitting systolic blood pressure (change from end of the run-in period to end of the treatment period)
Time frame: 16 weeks
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
Trough sitting diastolic and systolic blood pressures at each evaluation
Time frame: 2 weeks
responder rate; rate of patients with normalized blood pressure
Time frame: 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)
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azilsartan and Olmesartan medoxomil in people with Essential Hypertension, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.