Essential Hypertension With Stable Angina and DyslipidemiaPhase 4ALIVENCT02400775
A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.
A Phase 4 study testing Azilsartan in people with Essential Hypertension With Stable Angina and Dyslipidemia, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32 weeks on coronary artery plaque in essential hypertensive patients with stable angina and dyslipidemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Essential Hypertension With Stable Angina and Dyslipidemia
- What is being tested?
- Azilsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to Apr 2016
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with essential hypertension with office blood pressure before the start of study treatment (Week 0) meeting the following criteria who are appropriate for azilsartan therapy in the opinion of the principal investigator or investigator
- Patients aged ≥ 75 years at the time of informed consent: Sitting systolic blood pressure ≥ 150 mmHg or sitting diastolic blood pressure ≥ 90 mmHg
- Patients aged < 75 years at the time of informed consent who concurrently have type 2 diabetes mellitus: Sitting systolic blood pressure ≥ 130 mmHg or sitting diastolic blood pressure ≥ 80 mmHg
- Patients aged < 75 years at the time of informed consent who concurrently have chronic kidney disease (CKD) with proteinuria: Sitting systolic blood pressure ≥ 130 mmHg or sitting diastolic blood pressure ≥ 80 mmHg
- Patients meeting none of the above: Sitting systolic blood pressure ≥ 140 mmHg or sitting diastolic blood pressure ≥ 90 mmHg
- Patients with stable angina with a coronary stenosis confirmed by coronary angiography who are planned to undergo percutaneous coronary intervention with stent placement (any type of stent)
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- Patients with findings of integrated backscatter intravascular ultrasound (IB-IVUS) to be performed before the start of study treatment (Week 0) showing plaque at (≥ 5 mm in length) ≥ 5 mm proximal to the proximal end of the inserted stent in the coronary artery
- Patients with dyslipidemia meeting both of the following criteria:
- Patients treated with one HMG-CoA reductase inhibitor with no change in the dosage for at least 12 weeks before informed consent
- Patients with an LDL-C level of < 100 mg/dL as shown by a laboratory test performed within 4 weeks before informed consent
- Men or women aged 20 or older at the time of informed consent
- Patients capable of making outpatient study visits throughout the observation period
- Patients who, in the opinion of the principal investigator or investigator, are capable of understanding the contents of the clinical study and complying with the study requirements
- Patients capable of providing written consent in person before any study procedures
Who cannot join
- Patients with secondary hypertension or malignant hypertension
- Patients who took any renin-angiotensin system inhibitor within 12 weeks before informed consent
- Patients who previously underwent coronary artery bypass grafting
- Patients with type 1 diabetes mellitus
- Patients with insulin therapy
- Patients with an HbA1c level (National Glycohemoglobin Standardization Program [NGSP] value) of ≥ 7.0% as shown by a laboratory test performed within 4 weeks before informed consent
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- Patients with the plaque unevaluable because of severe calcification of the coronary artery shown by IB-IVUS to be performed before the start of study treatment (Week 0)
- Patients with a change to their antidyslipidemic medication (including a change to the dosage) within 12 weeks before informed consent
- Patients with clinically evident renal disorder (defined as estimated glomerular filtration rate < 30 mL/min/1.73m2)
- Patients with severe liver disorder
- Patients with hyperkalemia (defined as serum potassium ≥ 5.5 mEq/L)
- Patients with a history of hypersensitivity or allergy to azilsartan
- Patients participating in any other clinical study
- Pregnant women, women with possible pregnancy, or breastfeeding women
- Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32 weeks on coronary artery plaque in essential hypertensive patients with stable angina and dyslipidemia.
Read the detailed description
The open-label design without a control group was selected because this clinical study primarily aims to explore the effects of azilsartan on coronary artery plaques.
This study targeting patients with coronary artery plaque has been designed to enroll hypertensive patients with dyslipidemia. Also in light of the invasive nature of the major assessment procedures (i.e., IB-IVUS, OCT), this study will only enroll patients with stable angina planned to undergo percutaneous coronary intervention with stent placement, among patients with coronary artery plaque.
The starting dose of azilsartan has been set to 20 mg on the basis of the usual clinical dose of the drug in patients with essential hypertension, and dose increase of azilsartan will be permitted only when the target blood pressure has not been achieved.
The duration of treatment has been set to 32 weeks in line with clinical practice, in which coronary angiography is typically performed after a 32-week follow-up period following PCI with stent placement.
- Being tested
- Azilsartan
- Keywords
- Pharmacotherapy
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzilsartanDrug
Also called Azilva tablets
Azilsartan tablets
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan | Experimental | Azilsartan orally once daily in the morning, either before or after breakfast Receives: Drug: Azilsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of the lipid pool in the coronary artery plaque
Change in percentage of the lipid pool in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32).
Percentage of the lipid pool in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Measured: 32 weeks
Secondary outcomes (5)
Change in volume of the coronary artery plaque
Change in the volume of the coronary artery plaque from the start of the treatment period to the end of the treatment period.
Change from baseline in volume of the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Measured: 32 weeks
Change in percentage of the fibrotic component in the coronary artery plaque
Change in percentage of the fibrotic component in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32).
Percentage of the fibrotic component in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Measured: 32 weeks
Change in percentage of the calcified component in the coronary artery plaque
Change in percentage of the calcified component in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32).
Percentage of the calcified component in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Measured: 32 weeks
Change in number of microchannels
Change from baseline in number of microchannels is measured by Optical Coherence Tomography(OCT).
Measured: 32 weeks
Change in thickness of the fibrous cap
Change from baseline in number of microchannels is measured by Optical Coherence Tomography(OCT).
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Hypertension With Stable Angina and DyslipidemiaStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400775
- Sponsor's protocol ID
- Azilsartan-4001
- Other IDs
- U1111-1167-9135, JapicCTI-152834
- Acronym
- ALIVE
- Status last verified
- May 2016
- First submitted
- 10 Mar 2015
- Last updated
- 24 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.
- ClinicalTrials.gov ID
- NCT02400775
- Acronym / sponsor ID
- ALIVE / Azilsartan-4001
- Keywords
- Pharmacotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Mar 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.
The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32 weeks on coronary artery plaque in essential hypertensive patients with stable angina and dyslipidemia.
Detailed description
The open-label design without a control group was selected because this clinical study primarily aims to explore the effects of azilsartan on coronary artery plaques.
This study targeting patients with coronary artery plaque has been designed to enroll hypertensive patients with dyslipidemia. Also in light of the invasive nature of the major assessment procedures (i.e., IB-IVUS, OCT), this study will only enroll patients with stable angina planned to undergo percutaneous coronary intervention with stent placement, among patients with coronary artery plaque.
The starting dose of azilsartan has been set to 20 mg on the basis of the usual clinical dose of the drug in patients with essential hypertension, and dose increase of azilsartan will be permitted only when the target blood pressure has not been achieved.
The duration of treatment has been set to 32 weeks in line with clinical practice, in which coronary angiography is typically performed after a 32-week follow-up period following PCI with stent placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azilsartan | Experimental | Drug: AzilsartanAzilsartan orally once daily in the morning, either before or after breakfast |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with essential hypertension with office blood pressure before the start of study treatment (Week 0) meeting the following criteria who are appropriate for azilsartan therapy in the opinion of the principal investigator or investigator
- Patients with stable angina with a coronary stenosis confirmed by coronary angiography who are planned to undergo percutaneous coronary intervention with stent placement (any type of stent)
- Patients with findings of integrated backscatter intravascular ultrasound (IB-IVUS) to be performed before the start of study treatment (Week 0) showing plaque at (≥ 5 mm in length) ≥ 5 mm proximal to the proximal end of the inserted stent in the coronary artery
- Patients with dyslipidemia meeting both of the following criteria:
- Men or women aged 20 or older at the time of informed consent
Key exclusion criteria (15 listed)
- Patients with secondary hypertension or malignant hypertension
- Patients who took any renin-angiotensin system inhibitor within 12 weeks before informed consent
- Patients who previously underwent coronary artery bypass grafting
- Patients with type 1 diabetes mellitus
- Patients with insulin therapy
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 |
|---|---|---|
| AzilsartanAlso: Azilva tabletsAzilsartan tablets | Drug | Azilsartan |
Primary outcome
Change in percentage of the lipid pool in the coronary artery plaque
Time frame: 32 weeks
Change in percentage of the lipid pool in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32). Percentage of the lipid pool in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
5 secondary outcomes
Change in volume of the coronary artery plaque
Time frame: 32 weeks
Change in percentage of the fibrotic component in the coronary artery plaque
Time frame: 32 weeks
Change in percentage of the calcified component in the coronary artery plaque
Time frame: 32 weeks
Change in number of microchannels
Time frame: 32 weeks
Change in thickness of the fibrous cap
Time frame: 32 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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.
General Manager study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azilsartan in people with Essential Hypertension With Stable Angina and Dyslipidemia, run by Takeda at 1 site in Japan.
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 14 inclusion and 15 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: withdrawn, as of the sponsor's last update on 24 May 2016. 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 Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in percentage of the lipid pool in the coronary artery plaque (time frame: 32 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 24 May 2016.