HypertensionPhase 3NCT02609490
Azilsartan in Chinese Patients With Mild and Moderate Hypertension
A Phase 3 study testing Azilsartan tablets and Olmesartan medoxomil tablets in people with Hypertension, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Azilsartan tablets and Olmesartan medoxomil tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Aug 2018
- 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
- 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.
Who cannot join
- 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%).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients
- Conditions
- Hypertension
- Being tested
- Azilsartan tablets, Azilsartan placebo tablets, Olmesartan medoxomil tablets, olmesartan medoxomil placebo tablets
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan tabletsDrug
20mg/tablet
Azilsartan placebo tabletsDrug
placebo tablet
Olmesartan medoxomil tabletsDrug
20mg/tablet
olmesartan medoxomil placebo tabletsDrug
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Azilsartan | Experimental | Azilsartan tabelts Receives: Drug: Azilsartan tablets; Drug: olmesartan medoxomil placebo tablets |
| Positive Control-olmesartan medoxomil | Active comparator | olmesartan medoxomil tablets Receives: Drug: Azilsartan placebo tablets; Drug: Olmesartan medoxomil tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of sitting diastolic blood pressure at week 16
Measured: 16 weeks
Secondary outcomes (9)
Decrease of sitting diastolic blood pressure at week 8
Measured: 8 weeks
Decrease of sitting systolic blood pressure at week 8
Measured: 8 weeks
Decrease of sitting diastolic blood pressure at week 2
Measured: 2 weeks
Decrease of sitting diastolic blood pressure at week 4
Measured: 4 weeks
Decrease of sitting diastolic blood pressure at week 12
Measured: 12weeks
Decrease of sitting systolic blood pressure at week 2
Measured: 2 weeks
Decrease of sitting systolic blood pressure at week 4
Measured: 4 weeks
Decrease of sitting systolic blood pressure at week 12
Measured: 12 weeks
decrease of 24-hour ambulatory blood pressure monitoring at week 16
do a 24-hour ambulatory blood pressure monitoring at baseline and at week 16, compare the decrease.
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609490
- Sponsor's protocol ID
- Zhaoke-201505-Azilsartan
- Status last verified
- Aug 2018
- First submitted
- 17 Nov 2015
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02609490
- Acronym / sponsor ID
- Zhaoke-201505-Azilsartan
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Nov 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.
A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients
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 |
|---|---|---|
| Treatment-Azilsartan | Experimental | Drug: Azilsartan tablets, Drug: olmesartan medoxomil placebo tabletsAzilsartan tabelts |
| Positive Control-olmesartan medoxomil | Active comparator | Drug: Azilsartan placebo tablets, Drug: Olmesartan medoxomil tabletsolmesartan medoxomil tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 tablets20mg/tablet | Drug | Treatment-Azilsartan |
| Azilsartan placebo tabletsplacebo tablet | Drug | Positive Control-olmesartan medoxomil |
| Olmesartan medoxomil tablets20mg/tablet | Drug | Positive Control-olmesartan medoxomil |
| olmesartan medoxomil placebo tabletsplacebo tablet | Drug | Treatment-Azilsartan |
Primary outcome
Decrease of sitting diastolic blood pressure at week 16
Time frame: 16 weeks
9 secondary outcomes
Decrease of sitting diastolic blood pressure at week 8
Time frame: 8 weeks
Decrease of sitting systolic blood pressure at week 8
Time frame: 8 weeks
Decrease of sitting diastolic blood pressure at week 2
Time frame: 2 weeks
Decrease of sitting diastolic blood pressure at week 4
Time frame: 4 weeks
Decrease of sitting diastolic blood pressure at week 12
Time frame: 12weeks
Decrease of sitting systolic blood pressure at week 2
Time frame: 2 weeks
Decrease of sitting systolic blood pressure at week 4
Time frame: 4 weeks
Decrease of sitting systolic blood pressure at week 12
Time frame: 12 weeks
decrease of 24-hour ambulatory blood pressure monitoring at week 16
Time frame: 16 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 tablets and Olmesartan medoxomil tablets in people with Hypertension, run by Lee's Pharmaceutical Limited 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 4 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of sitting diastolic blood pressure at week 16 (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 4 Sep 2018.