Grade I or II Essential HypertensionPhase 2/3NCT02072330
Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
A Phase 2/3 study testing TAK-536CCB, TAK-536CCB + Hydrochlorothiazide and Hydrochlorothiazide in people with Grade I or II Essential Hypertension, run by Takeda at 13 sites in Japan.
Trial summary
The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Grade I or II Essential Hypertension
- What is being tested?
- TAK-536CCB, TAK-536CCB + Hydrochlorothiazide and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 13 sitesJapan
- Study dates
- Mar 2013to Dec 2013
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I or II essential hypertension.
- An office sitting systolic blood pressure of ≥ 150 and < 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmHg during the placebo run-in period at Week -2 and Week 0.
- Male or female aged 20 years or older at the time of providing informed consent.
- Outpatient.
Who cannot join
- Secondary hypertension, grade III hypertension or malignant hypertension.
- An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.
- 3 Evident white coat hypertension or white coat phenomenon. 4. Day-night reversed lifestyle, such as night-time workers. 5. Sleep apnea syndrome requiring treatment. 6. Have any of the cardiovascular disease or symptoms listed below:
- Heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia.
- Cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period).
- Vascular diseases: peripheral arterial disease with intermittent claudication, artery dissection, aneurysm
Show all 10Show fewer
- Advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period).
- 7. Clinically significant hepatic disorder. 8. Clinically significant renal impairment. 9. Significantly low or high Potassium or Sodium levels. 10. Complicated by gout, or had a past history of gout within 24 weeks prior to the initiation of the placebo run-in period, or complicated by hyperuricemia requiring medication.
- 11. Diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus.
- 12. Have a malignant tumor.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Study site
Fukuoka, Fukuoka
Study site
Hanamaki-shi, Iwate
Study site
Hiroshima, Hiroshima
Study site
Kumamoto, Kumamoto
Study site
Kyoto, Kyoto
Study site
Morioka, Iwate
Study site
Osaka, Osaka
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Shinjuku-ku, Tokyo
Study site
Suita-shi, Osaka
Study site
Touon-shi, Ehime
Study site
Toyama, Toyama
About this study
Official title: A Randomized, Double-Blind, Multicenter, Phase 2/3 Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB (Fix-dose Combination of Azilsartan and Amlodipine) and Hydrochlorothiazide in Comparison With TAK-536CCB or Hydrochlorothiazide Monotherapy in Patients With Grade I or II Essential Hypertension
The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.
Read the detailed description
This study is a randomized, double-blind, multicenter, phase 2/3 study to evaluate the efficacy and safety of combined administration of TAK-536CCB and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB or Hydrochlorothiazide in patients with grade I or II essential hypertension.
This study consists of a 4-week single-blind placebo run-in period and a 10-week double-blind treatment period.
- Conditions
- Grade I or II Essential Hypertension
- Being tested
- TAK-536CCB, TAK-536CCB + Hydrochlorothiazide, Hydrochlorothiazide
- Keywords
- Hypertension, Drug therapy
- Medical subject headings
- Lymphoma, Follicular, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-536CCBDrug
Also called Fix-dose combination of Azilsartan and Amlodipine
TAK-536CCB 20 mg/5 mg ＋Hydrochlorothiazide placebo tablets
TAK-536CCB + HydrochlorothiazideDrug
Also called Hydrochlorothiazide and fix-dose combination of Azilsartan and Amlodipine
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets
HydrochlorothiazideDrug
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets
HydrochlorothiazideDrug
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets x2
TAK-536CCB + HydrochlorothiazideDrug
Also called Hydrochlorothiazide and fix-dose combination of Azilsartan and Amlodipine
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets x2
| Study group | Role | What they receive |
|---|---|---|
| TAK-536CCB 20 mg/5 mg ＋Placebo (dual therapy) | Active comparator | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide (HCTZ) placebo for 10 weeks Receives: Drug: TAK-536CCB |
| TAK-536CCB 20 mg/5 mg ＋HCTZ 6.25 mg (triple therapy) | Experimental | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo (triple therapy) for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 6.25 mg for the remaining 8 weeks. Receives: Drug: TAK-536CCB + Hydrochlorothiazide |
| TAK-536CCB 20 mg/5 mg ＋HCTZ 12.5 mg (triple therapy) | Experimental | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 12.5 mg (triple therapy) for the remaining 8 weeks. Receives: Drug: TAK-536CCB + Hydrochlorothiazide |
| Placebo ＋HCTZ 6.25 mg (HCTZ monotherapy) | Active comparator | TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period. Receives: Drug: Hydrochlorothiazide |
| Placebo ＋Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) | Active comparator | TAK-536CCB placebo and Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period. Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the office trough sitting diastolic blood pressure (DBP)
Change in the office trough sitting DBP from the end of the placebo run-in period (baseline [Week 0]) to the end of the treatment period (Week 10, last observation carried forward [LOCF])
Measured: Baseline and Week 10
Secondary outcomes (6)
Change from Baseline in the office trough sitting systolic blood pressure (SBP)
Change in the office trough sitting SBP from the end of the placebo run-in period (baseline [Week 0]) to the end of the treatment period (Week 10, last observation carried forward [LOCF])
Measured: Baseline and Week 10
Proportion of patients achieving < 140/90 mmHg
Patients achieving < 140/90 mmHg refer to those meeting both of the following criteria:
- A decrease to < 90 mmHg in office trough sitting DBP
- A decrease to < 140 mmHg in office trough sitting SBP
Measured: 10 weeks
Proportion of responders (140/90 mmHg criterion)
Patients who met either of the following conditions are regarded as responders (140/90 mmHg criterion).
- A ≥ 20 mmHg decrease in office trough sitting SBP and a ≥ 10 mmHg decrease in the office trough sitting DBP
- A decrease to < 140 mmHg in office trough sitting SBP and a decrease to < 90 mmHg in office trough sitting DBP
Measured: 10 weeks
Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests)
The frequency of adverse events by type, seriousness. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug
Measured: 10 weeks
Time profile of office trough sitting diastolic blood pressure
Measured: 10 weeks
Time profile of office trough sitting systolic blood pressure
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade I or II 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072330
- Sponsor's protocol ID
- TAK-536TCH/CCT-001
- Other IDs
- JapicCTI-121962
- Status last verified
- Feb 2014
- First submitted
- 24 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Phase 2/3 Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB (Fix-dose Combination of Azilsartan and Amlodipine) and Hydrochlorothiazide in Comparison With TAK-536CCB or Hydrochlorothiazide Monotherapy in Patients With Grade I or II Essential Hypertension
- ClinicalTrials.gov ID
- NCT02072330
- Acronym / sponsor ID
- TAK-536TCH/CCT-001
- Conditions
- Grade I or II Essential Hypertension
- Keywords
- Hypertension, Drug therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2014 (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 objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.
Detailed description
This study is a randomized, double-blind, multicenter, phase 2/3 study to evaluate the efficacy and safety of combined administration of TAK-536CCB and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB or Hydrochlorothiazide in patients with grade I or II essential hypertension.
This study consists of a 4-week single-blind placebo run-in period and a 10-week double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TAK-536CCB 20 mg/5 mg ＋Placebo (dual therapy) | Active comparator | Drug: TAK-536CCBTAK-536CCB 20 mg/5 mg and Hydrochlorothiazide (HCTZ) placebo for 10 weeks |
| TAK-536CCB 20 mg/5 mg ＋HCTZ 6.25 mg (triple therapy) | Experimental | Drug: TAK-536CCB + HydrochlorothiazideTAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo (triple therapy) for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 6.25 mg for the remaining 8 weeks. |
| TAK-536CCB 20 mg/5 mg ＋HCTZ 12.5 mg (triple therapy) | Experimental | Drug: TAK-536CCB + HydrochlorothiazideTAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 12.5 mg (triple therapy) for the remaining 8 weeks. |
| Placebo ＋HCTZ 6.25 mg (HCTZ monotherapy) | Active comparator | Drug: HydrochlorothiazideTAK-536CCB placebo and Hydrochlorothiazide 6.25 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period. |
| Placebo ＋Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) | Active comparator | Drug: HydrochlorothiazideTAK-536CCB placebo and Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Grade I or II essential hypertension.
- An office sitting systolic blood pressure of ≥ 150 and < 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmHg during the placebo run-in period at Week -2 and Week 0.
- Male or female aged 20 years or older at the time of providing informed consent.
- Outpatient.
Key exclusion criteria (10 listed)
- Secondary hypertension, grade III hypertension or malignant hypertension.
- An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.
- 3 Evident white coat hypertension or white coat phenomenon. 4. Day-night reversed lifestyle, such as night-time workers. 5. Sleep apnea syndrome requiring treatment. 6. Have any of the cardiovascular disease or symptoms listed below:
- Heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia.
- Cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period).
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 |
|---|---|---|
| TAK-536CCBAlso: Fix-dose combination of Azilsartan and AmlodipineTAK-536CCB 20 mg/5 mg ＋Hydrochlorothiazide placebo tablets | Drug | TAK-536CCB 20 mg/5 mg ＋Placebo (dual therapy) |
| TAK-536CCB + HydrochlorothiazideAlso: Hydrochlorothiazide and fix-dose combination of Azilsartan and AmlodipineTAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets | Drug | TAK-536CCB 20 mg/5 mg ＋HCTZ 6.25 mg (triple therapy) |
| HydrochlorothiazideTAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets | Drug | Placebo ＋HCTZ 6.25 mg (HCTZ monotherapy) |
| HydrochlorothiazideTAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets x2 | Drug | Placebo ＋Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) |
| TAK-536CCB + HydrochlorothiazideAlso: Hydrochlorothiazide and fix-dose combination of Azilsartan and AmlodipineTAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets x2 | Drug | TAK-536CCB 20 mg/5 mg ＋HCTZ 12.5 mg (triple therapy) |
Primary outcome
Change from Baseline in the office trough sitting diastolic blood pressure (DBP)
Time frame: Baseline and Week 10
Change in the office trough sitting DBP from the end of the placebo run-in period (baseline [Week 0]) to the end of the treatment period (Week 10, last observation carried forward [LOCF])
6 secondary outcomes
Change from Baseline in the office trough sitting systolic blood pressure (SBP)
Time frame: Baseline and Week 10
Proportion of patients achieving < 140/90 mmHg
Time frame: 10 weeks
Proportion of responders (140/90 mmHg criterion)
Time frame: 10 weeks
Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests)
Time frame: 10 weeks
Time profile of office trough sitting diastolic blood pressure
Time frame: 10 weeks
Time profile of office trough sitting systolic blood pressure
Time frame: 10 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 26 Feb 2014.
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.
Senior Manager study director
Takeda
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TAK-536CCB, TAK-536CCB + Hydrochlorothiazide and Hydrochlorothiazide in people with Grade I or II Essential Hypertension, run by Takeda at 13 sites 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 4 inclusion and 10 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 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 combined 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.
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?
Change from Baseline in the office trough sitting diastolic blood pressure (DBP) (time frame: Baseline and Week 10). 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 26 Feb 2014.