Essential HypertensionPhase 2NCT01289132
Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension
A Phase 2 study testing Azilsartan and Candesartan cilexetil in people with Essential Hypertension, run by Takeda.
Trial summary
The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Azilsartan and Candesartan cilexetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 926 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jul 2008
- Phase
- Phase 2
- 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
- Has mild to moderate uncomplicated essential hypertension.
- Has a sitting diastolic blood pressure between 95 and <110 mmHg and sitting systolic blood pressure between 150 and <180 mmHg at placebo run-in period (Week -2) or randomization visit.
Who cannot join
- Has a cardiovascular disease or symptoms
- Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.
- Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-536 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension
The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.
Read the detailed description
Hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. This becomes a medically and medical-economically significant problem in Japan The significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year.
Takeda Pharmaceutical Company Limited invented TAK-536 (azilsartan), an angiotensin II receptor blocker for decreasing blood pressure. This study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.
- Conditions
- Essential Hypertension
- Being tested
- Placebo, Azilsartan, Candesartan cilexetil
- Keywords
- Drug Therapy
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo-matching tablets, orally, once daily for up to 12 weeks.
AzilsartanDrug
Also called TAK-536
Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.
AzilsartanDrug
Also called TAK-536
Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.
AzilsartanDrug
Also called TAK-536
Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.
AzilsartanDrug
Also called TAK-536
Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.
AzilsartanDrug
Also called TAK-536
Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.
Candesartan cilexetilDrug
Also called Blopress®, TCV-116
Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Azilsartan 5 mg QD | Experimental | Not described Receives: Drug: Azilsartan |
| Azilsartan 10 mg QD | Experimental | Not described Receives: Drug: Azilsartan |
| Azilsartan 20 mg QD | Experimental | Not described Receives: Drug: Azilsartan |
| Azilsartan 40 mg QD | Experimental | Not described Receives: Drug: Azilsartan |
| Azilsartan 80 mg QD | Experimental | Not described Receives: Drug: Azilsartan |
| Candesartan Cilexetil 8 mg titrated to12 mg QD | Active comparator | Not described Receives: Drug: Candesartan cilexetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).
The change between sitting trough clinic diastolic blood pressure measured at week 12 or final visit from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 12.
Secondary outcomes (25)
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).
The change between sitting trough clinic diastolic blood pressure measured at week 2 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 2.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).
The change between sitting trough clinic diastolic blood pressure measured at week 4 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 4.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).
The change between sitting trough clinic diastolic blood pressure measured at week 6 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 6.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).
The change between sitting trough clinic diastolic blood pressure measured at week 8 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 8.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).
The change between sitting trough clinic diastolic blood pressure measured at week 10 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 10.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2).
The change between sitting trough clinic systolic blood pressure measured at week 2 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 2.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4).
The change between sitting trough clinic systolic blood pressure measured at week 4 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 4.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6).
The change between sitting trough clinic systolic blood pressure measured at week 6 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 6.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8).
The change between sitting trough clinic systolic blood pressure measured at week 8 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 8.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10).
The change between sitting trough clinic systolic blood pressure measured at week 10 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 10.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12).
The change between sitting trough clinic systolic blood pressure measured at week 12 or final visit from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: Baseline and Week 12.
Number of Participants with a ≥20 mmHg Decrease in Sitting Trough Systolic Blood Pressure and a ≥10 mmHg Decrease in Sitting Trough Diastolic Blood Pressure.
Number of participants designated as responders who have a ≥20 mmHg Decrease in sitting trough systolic blood pressure and a ≥10 mmHg Decrease in sitting trough diastolic blood pressure at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Number of Participants with a Sitting Trough Systolic Blood Pressure of <130 mmHg and a Sitting Trough Diastolic Blood Pressure of <85 mmHg.
Number of participants designated as responders with a sitting trough systolic blood pressure of <130 mmHg and a sitting trough diastolic blood pressure of <85 mmHg at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Incidence of Adverse Events.
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Measured: On occurrence (up to Week 12).
Change from Baseline in Supine Systolic Blood Pressure.
The change between supine systolic blood pressure measured at week 12 or final visit from baseline. Supine systolic blood pressure is measured in participants laying on their back in a face-up position once after resting for 2 minutes.
Measured: Baseline and Week 12.
Change from Baseline in Supine Diastolic Blood Pressure.
The change between supine diastolic blood pressure measured at week 12 or final visit from baseline. Supine diastolic blood pressure is measured in participants laying on their back in a face-up position once after resting for 2 minutes.
Measured: Baseline and Week 12.
Change from Baseline in Standing Systolic Blood Pressure.
The change between standing systolic blood pressure measured at week 12 or final visit from baseline. Standing systolic blood pressure is measured once after participants keep a standing position for 1 minute.
Measured: Baseline and Week 12.
Change from Baseline in Standing Diastolic Blood Pressure.
The change between standing diastolic blood pressure measured at week 12 or final visit from baseline. Standing diastolic blood pressure is measured once after participants keep a standing position for 1 minute.
Measured: Baseline and Week 12.
Change from Baseline in Sitting Pulse Rate.
The change between sitting pulse rate measured at week 12 or final visit from baseline. Sitting pulse rate is measured at least 3 times in 1- to 2-minute intervals after sitting ≥5 minutes, repeated until 2 consecutive stable measurements are obtained.
Measured: Baseline and Week 12.
Change from Baseline in Weight.
The change between weight recorded at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Change from Baseline in Resting 12-lead Electrocardiogram.
The change between electrocardiogram recorded at week 12 or final visit from baseline. Electrocardiogram interpreted using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Measured: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value.
The number of participants with a markedly abnormal blood urea value nitrogen collected at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value.
The number of participants with a markedly abnormal uric acid value collected at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value.
The number of participants with a markedly abnormal creatinine value collected at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value.
The number of participants with a markedly abnormal creatine kinase value collected at week 12 or final visit from baseline.
Measured: Baseline and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor Geriatric Medicine and Nephrology, Study director, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289132
- Sponsor's protocol ID
- TAK-536/CCT-001
- Other IDs
- U1111-1118-3346
- Status last verified
- Feb 2011
- First submitted
- 1 Feb 2011
- Last updated
- 3 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-536 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension
- ClinicalTrials.gov ID
- NCT01289132
- Acronym / sponsor ID
- TAK-536/CCT-001
- Conditions
- Essential Hypertension
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 926 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Feb 2011 (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 was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.
Detailed description
Hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. This becomes a medically and medical-economically significant problem in Japan The significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year.
Takeda Pharmaceutical Company Limited invented TAK-536 (azilsartan), an angiotensin II receptor blocker for decreasing blood pressure. This study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Azilsartan 5 mg QD | Experimental | Drug: Azilsartan |
| Azilsartan 10 mg QD | Experimental | Drug: Azilsartan |
| Azilsartan 20 mg QD | Experimental | Drug: Azilsartan |
| Azilsartan 40 mg QD | Experimental | Drug: Azilsartan |
| Azilsartan 80 mg QD | Experimental | Drug: Azilsartan |
| Candesartan Cilexetil 8 mg titrated to12 mg QD | Active comparator | Drug: Candesartan cilexetil |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has mild to moderate uncomplicated essential hypertension.
- Has a sitting diastolic blood pressure between 95 and <110 mmHg and sitting systolic blood pressure between 150 and <180 mmHg at placebo run-in period (Week -2) or randomization visit.
Key exclusion criteria (3 listed)
- Has a cardiovascular disease or symptoms
- Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.
- Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.
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 |
|---|---|---|
| PlaceboPlacebo-matching tablets, orally, once daily for up to 12 weeks. | Drug | Placebo |
| AzilsartanAlso: TAK-536Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Azilsartan 5 mg QD |
| AzilsartanAlso: TAK-536Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Azilsartan 10 mg QD |
| AzilsartanAlso: TAK-536Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Azilsartan 20 mg QD |
| AzilsartanAlso: TAK-536Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Azilsartan 40 mg QD |
| AzilsartanAlso: TAK-536Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Azilsartan 80 mg QD |
| Candesartan cilexetilAlso: Blopress®, TCV-116Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks. | Drug | Candesartan Cilexetil 8 mg titrated to12 mg QD |
Primary outcome
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).
Time frame: Baseline and Week 12.
The change between sitting trough clinic diastolic blood pressure measured at week 12 or final visit from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
25 secondary outcomes
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).
Time frame: Baseline and Week 2.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).
Time frame: Baseline and Week 4.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).
Time frame: Baseline and Week 6.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).
Time frame: Baseline and Week 8.
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).
Time frame: Baseline and Week 10.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2).
Time frame: Baseline and Week 2.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4).
Time frame: Baseline and Week 4.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6).
Time frame: Baseline and Week 6.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8).
Time frame: Baseline and Week 8.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10).
Time frame: Baseline and Week 10.
Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12).
Time frame: Baseline and Week 12.
Number of Participants with a ≥20 mmHg Decrease in Sitting Trough Systolic Blood Pressure and a ≥10 mmHg Decrease in Sitting Trough Diastolic Blood Pressure.
Time frame: Baseline and Week 12.
Number of Participants with a Sitting Trough Systolic Blood Pressure of <130 mmHg and a Sitting Trough Diastolic Blood Pressure of <85 mmHg.
Time frame: Baseline and Week 12.
Incidence of Adverse Events.
Time frame: On occurrence (up to Week 12).
Change from Baseline in Supine Systolic Blood Pressure.
Time frame: Baseline and Week 12.
Change from Baseline in Supine Diastolic Blood Pressure.
Time frame: Baseline and Week 12.
Change from Baseline in Standing Systolic Blood Pressure.
Time frame: Baseline and Week 12.
Change from Baseline in Standing Diastolic Blood Pressure.
Time frame: Baseline and Week 12.
Change from Baseline in Sitting Pulse Rate.
Time frame: Baseline and Week 12.
Change from Baseline in Weight.
Time frame: Baseline and Week 12.
Change from Baseline in Resting 12-lead Electrocardiogram.
Time frame: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value.
Time frame: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value.
Time frame: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value.
Time frame: Baseline and Week 12.
Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value.
Time frame: Baseline and Week 12.
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 3 Feb 2011.
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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.
Professor Geriatric Medicine and Nephrology study director
Osaka University Graduate School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azilsartan and Candesartan cilexetil in people with Essential Hypertension, run by Takeda.
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 3 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12). (time frame: Baseline and Week 12.). 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 3 Feb 2011.