HypertensionPhase 4NCT00492128
Kanagawa Combination Anti-hypertensive Therapy (K-CAT)
A Phase 4 study testing Losartan/amlodipine or losartan/hydrochlorothiazide in people with Hypertension, run by Yokohama City University Medical Center at 1 site in Japan.
Trial summary
The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan/amlodipine or losartan/hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2007to Aug 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under treatment of hypertension with ARB monotherapy for more than one month.
- systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
- In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.
Who cannot join
- uncontrolled hypertension (diastolic blood pressure >120mmHg)
- uncontrolled diabetes mellitus (HbA1c>9.0%)
- Acute myocardial infarction, stroke and other cardiovascular events within six months
- The history of gout, or uric acid>8.0mg/dl
- Serum creatinine>2.0mg/dl
- sever liver dysfunction
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- Bilateral renovascular stenosis
- secondary hypertension
- malignant hypertension
- uncontrolled arrhythmia
- pregnancy or possibility of pregnancy
- hypersensitivity to trial drug
Trial locations and contacts
1 site in 1 country.
Japan1 site
Yokohama City University Graduate School of Medicine
Yokohama, Kanagawa, 236-0004
About this study
Official title: Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB
The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
Read the detailed description
The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
- Conditions
- Hypertension
- Being tested
- Losartan/amlodipine or losartan/hydrochlorothiazide
- Keywords
- hypertension, angiotensin receptor blocker, diuretic, combination therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan/amlodipine or losartan/hydrochlorothiazideDrug
Also called Preminent (Hyzaar)
Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Losartan/hydrochlorothiazide | Experimental | Combination drug with losartan 50mg and hydrochlorothiazide 12.5mg Receives: Drug: Losartan/amlodipine or losartan/hydrochlorothiazide |
| Losartan/amlodipine | Active comparator | Combination therapy with losartan 50mg and amlodopine 5mg Receives: Drug: Losartan/amlodipine or losartan/hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of systolic blood pressure
Measured: three months
Secondary outcomes (4)
The achievement rate of target blood pressure
Measured: three months
The change of diastolic blood pressure
Measured: three months
The change of blood pressure
Measured: six months, nine months and one year
The achievement rate of target blood pressure
Measured: six months, nine months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2009
- Study completionAug 2010
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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoshi Umemura, Yokohama City University Medical Center
- Investigators
- Satoshi Umemura, MD, PhD, Study chair, Yokohama City University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492128
- Sponsor's protocol ID
- 200706001
- Status last verified
- Jan 2015
- First submitted
- 26 Jun 2007
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB
- ClinicalTrials.gov ID
- NCT00492128
- Acronym / sponsor ID
- 200706001
- Conditions
- Hypertension
- Keywords
- hypertension, angiotensin receptor blocker, diuretic, combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Jun 2007 (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 the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
Detailed description
The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan/hydrochlorothiazide | Experimental | Drug: Losartan/amlodipine or losartan/hydrochlorothiazideCombination drug with losartan 50mg and hydrochlorothiazide 12.5mg |
| Losartan/amlodipine | Active comparator | Drug: Losartan/amlodipine or losartan/hydrochlorothiazideCombination therapy with losartan 50mg and amlodopine 5mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Under treatment of hypertension with ARB monotherapy for more than one month.
- systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
- In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.
Key exclusion criteria (12 listed)
- uncontrolled hypertension (diastolic blood pressure >120mmHg)
- uncontrolled diabetes mellitus (HbA1c>9.0%)
- Acute myocardial infarction, stroke and other cardiovascular events within six months
- The history of gout, or uric acid>8.0mg/dl
- Serum creatinine>2.0mg/dl
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 |
|---|---|---|
| Losartan/amlodipine or losartan/hydrochlorothiazideAlso: Preminent (Hyzaar)Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months. | Drug | Losartan/amlodipine, Losartan/hydrochlorothiazide |
Primary outcome
The change of systolic blood pressure
Time frame: three months
4 secondary outcomes
The achievement rate of target blood pressure
Time frame: three months
The change of diastolic blood pressure
Time frame: three months
The change of blood pressure
Time frame: six months, nine months and one year
The achievement rate of target blood pressure
Time frame: six months, nine months and one year
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 Jan 2015.
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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.
Satoshi Umemura, MD, PhD study chair
Yokohama City University Graduate School of Medicine
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 Losartan/amlodipine or losartan/hydrochlorothiazide in people with Hypertension, run by Yokohama City University Medical Center 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 3 inclusion and 12 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 Jan 2015. 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?
The change of systolic blood pressure (time frame: three months). 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 Jan 2015.