HypertensionPhase 4NCT00198562
Hypertension Control Based on Home Blood Pressure
A Phase 4 study testing Amlodipine, Losartan in people with Hypertension, run by Ministry of Health, Labour and Welfare, Japan at 1 site in Japan.
Trial summary
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs. The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine, Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2000to Mar 2012
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension
Who cannot join
- Severe hypertension (treated with 3 or more antihypertensive drugs)
- Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
- Serious medical conditions
- Women who may become to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.
Read the detailed description
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.
- Conditions
- Hypertension
- Being tested
- Amlodipine, Losartan
- Keywords
- Antihypertensive therapy, Home blood pressure, Systolic blood pressure, Morning blood pressure, Calcium antagonist, Angiotensin receptor antagonist
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine, LosartanDrug
Also called other antihypertensive drugs (if required)
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | target morning home blood pressure (below 130 mmHg vs 130-139 mmHg) Receives: Drug: Amlodipine, Losartan |
| 2 | Active comparator | antihypertensive drug (amlodipine vs losartan) Receives: Drug: Amlodipine, Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined cardiovascular events
Measured: 5 years
Secondary outcomes (8)
Total mortality
Measured: 5 years
Cardiovascular mortality
Measured: 5 years
Myocardial infarction and new-onset angina
Measured: 5 years
Stroke and transient ischemic attack
Measured: 5 years
Renal failure
Measured: 5 years
Aortic and peripheral artery diseases
Measured: 5 years
Left ventricular mass and function
Measured: 5 years
Urinary albumin and renal function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2000
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Labour and Welfare, Japan
- Sponsor type
- Other government
- Collaborators
- Japan Cardiovascular Research Foundation
- Investigators
- Yuhei Kawano, M.D., Ph.D., Principal investigator, Division of Hypertension and Nephrology, National Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198562
- Sponsor's protocol ID
- H16-CV-001
- Other IDs
- 200400510B
- Status last verified
- Apr 2008
- First submitted
- 12 Sep 2005
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
- ClinicalTrials.gov ID
- NCT00198562
- Acronym / sponsor ID
- H16-CV-001
- Conditions
- Hypertension
- Keywords
- Antihypertensive therapy, Home blood pressure, Systolic blood pressure, Morning blood pressure, Calcium antagonist, Angiotensin receptor antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Ministry of Health, Labour and Welfare, JapanOther government
- Collaborators
- Japan Cardiovascular Research Foundation
- Study start
- Apr 2000
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 20 Sep 2005 (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 aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.
Detailed description
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Amlodipine, Losartantarget morning home blood pressure (below 130 mmHg vs 130-139 mmHg) |
| 2 | Active comparator | Drug: Amlodipine, Losartanantihypertensive drug (amlodipine vs losartan) |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of hypertension
Key exclusion criteria (4 listed)
- Severe hypertension (treated with 3 or more antihypertensive drugs)
- Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
- Serious medical conditions
- Women who may become to be pregnant
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 |
|---|---|---|
| Amlodipine, LosartanAlso: other antihypertensive drugs (if required)amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years | Drug | 1, 2 |
Primary outcome
Combined cardiovascular events
Time frame: 5 years
8 secondary outcomes
Total mortality
Time frame: 5 years
Cardiovascular mortality
Time frame: 5 years
Myocardial infarction and new-onset angina
Time frame: 5 years
Stroke and transient ischemic attack
Time frame: 5 years
Renal failure
Time frame: 5 years
Aortic and peripheral artery diseases
Time frame: 5 years
Left ventricular mass and function
Time frame: 5 years
Urinary albumin and renal function
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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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.
Yuhei Kawano, M.D., Ph.D. principal investigator
Division of Hypertension and Nephrology, National Cardiovascular Center
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 Amlodipine, Losartan in people with Hypertension, run by Ministry of Health, Labour and Welfare, Japan 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Apr 2008. 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?
Results are not available in the source record.
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?
Combined cardiovascular events (time frame: 5 years). 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 22 Apr 2008.