HypertensionPhase 4NARANCT01609959
New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering
A Phase 4 study testing Azilsartan and Valsartan in people with Hypertension, run by Nara Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Azilsartan and Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2012to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan
- Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.
Who cannot join
- Hypersensitivity for azilsartan and valsartan
- Pregnant female
- History of azilsartan use within 3 months
Trial locations and contacts
1 site in 1 country.
Japan1 site
First Department of Nara Medical University
Kashihara, Nara, 634-8522
About this study
Official title: Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension
The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.
Read the detailed description
Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor.
A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.
- Conditions
- Hypertension
- Being tested
- Azilsartan, Valsartan
- Keywords
- Hypertension, Angiotensin II Receptor Blocker, Azilsartan, Valsartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzilsartanDrug
Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
ValsartanDrug
Valsartan 160 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan group | Active comparator | Not described Receives: Drug: Azilsartan |
| Valsartan group | Active comparator | Not described Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Office Blood Pressure
Change in blood pressure measured at a clinic
Measured: Baseline and every 2 weeks (up to 12 weeks)
Secondary outcomes (5)
Change in Home Blood Pressure
Change in blood pressure measured at home
Blood pressure is measured twice daily in the morning fasting before taking any drugs.
Measured: Baseline and every 2 weeks (up to 12 weeks)
Change in Renal Function
Changes in levels of serum creatinine and proteinuria
Measured: Baseline and 12 weeks
Change in Fasting Triglyceride
Measured: Baseline and 12 weeks
Change in Glycemic Control
Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
Measured: Baseline and 12 weeks
Change in Plasma Aldosterone Concentration
Only in patients with secondary hypertension
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionOct 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nara Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiko Saito, Nara Medical University
- Investigators
- Yoshihiko Saito, MD, PhD, Principal investigator, First Department of Internal Medicine, Nara Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609959
- Sponsor's protocol ID
- 12-Ken-001
- Acronym
- NARA
- Status last verified
- Oct 2013
- First submitted
- 30 May 2012
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01609959
- Acronym / sponsor ID
- NARA / 12-Ken-001
- Conditions
- Hypertension
- Keywords
- Hypertension, Angiotensin II Receptor Blocker, Azilsartan, Valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nara Medical UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Jun 2012 (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 compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.
Detailed description
Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor.
A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azilsartan group | Active comparator | Drug: Azilsartan |
| Valsartan group | Active comparator | Drug: Valsartan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan
- Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.
Key exclusion criteria (3 listed)
- Hypersensitivity for azilsartan and valsartan
- Pregnant female
- History of azilsartan use within 3 months
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 |
|---|---|---|
| AzilsartanAzilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks | Drug | Azilsartan group |
| ValsartanValsartan 160 mg per day | Drug | Valsartan group |
Primary outcome
Change in Office Blood Pressure
Time frame: Baseline and every 2 weeks (up to 12 weeks)
Change in blood pressure measured at a clinic
5 secondary outcomes
Change in Home Blood Pressure
Time frame: Baseline and every 2 weeks (up to 12 weeks)
Change in Renal Function
Time frame: Baseline and 12 weeks
Change in Fasting Triglyceride
Time frame: Baseline and 12 weeks
Change in Glycemic Control
Time frame: Baseline and 12 weeks
Change in Plasma Aldosterone Concentration
Time frame: Baseline and 12 weeks
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 30 Oct 2013.
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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.
Yoshihiko Saito, MD, PhD principal investigator
First Department of Internal Medicine, Nara Medical University
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 and Valsartan in people with Hypertension, run by Nara Medical University 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 2 inclusion and 3 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 30 Oct 2013. 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 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?
Change in Office Blood Pressure (time frame: Baseline and every 2 weeks (up to 12 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 30 Oct 2013.