HypertensionPhase 4RESPECTSNCT01198496
Recurrent Stroke Prevention Clinical Outcome Study
A Phase 4 study testing Losartan, Losartan and HCTZ, Amlodipine , Spironolactone in people with Hypertension and Stroke, run by Biomedis International Ltd. at 1 site in Japan.
Trial summary
1. Objectives and Hypothesis 1. Objectives: This study evaluates whether strict BP management is useful for the prevention of recurrent stroke. Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group and less… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Hypertension, Stroke, Blood Pressure
- What is being tested?
- Losartan, Losartan and HCTZ, Amlodipine , Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2010to Dec 2019
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants include those with essential hypertension and history of stroke who satisfy the following criteria:
- Outpatient
- Onset of stroke(cerebral infarction/cerebral hemorrhage) occurred between 30 days and 3 years prior to the date of consent.
- Drug adherence is ≧80% during the screening period.
- Mean of 2 baseline BP measurements(measured at outpatient clinic) within 30 days prior to the date of consent is either 180 >SBP ≧130 mmHg or 110 >DBP ≧80 mmHg (untreated -3 anti hypertensive agents patients).
- Cerebral infarction with severity 3 or less in the modified Rankin scale.
Who cannot join
- Patient who meets any one of the following criteria is excluded from the study.
- Women who are pregnant, are possible pregnant, or are breastfeeding
- Possible secondary hypertension
- Severe hypertension (grade III or greater) with baseline SBP ≧180 mmHg or DBP ≧110 mmHg)
- Myocardial infarction or undergoing angioplasty occurred within 3 months prior to the screening.
- Current or previous heart failure with NYHA classification class III or more, or EF less than 35%
Show all 19Show fewer
- Severe bilateral carotid stenosis or major cerebral artery occlusion
- Severe paralysis due to stroke (modified Rankin scale ≧ 4 )
- Current renal dysfunction (serum Cr ≧ 2.0 mg/dL right before the date of consent)
- Current hepatic dysfunction with AST or ALT value ≧ 100 IU/mL right before the date of consent
- Refractory hypertension treated with four or more antihypertensive drugs
- Hypersensitivity or allergy to losartan and other angiotensin II receptor blockers, hydrochlorothiazide, amlodipine or sulfonamide derivative
- Major surgery planned during the study period
- Participants of other clinical studies within the last 30 days
- Current malignancy (previous malignancy within 5 years after the end of treatment) excluding squamous-cell skin cancer
- Previous and current subarachnoid hemorrhage
- Definitive dementia 12) (based on a clinical diagnosis)
- Patients who have difficulty in signing consent or who do not agree to the provided consent
- Patients who are judged to be unsuitable for participating the study by the primary investigator or sub-investigator.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Jichi Medical Univercity
Shimotsuke, Tochigi, 329-0498
Kazuyuki Shimada, MD, kazuyuki@jichi.ac.jp
Kazuomi Kario, MD
About this study
Official title: Phase IV Study for Effect of Intensive Blood-Pressure Control Using Anti-hypertensive Agents in Essential Hypertension With History of Stroke
- Objectives and Hypothesis
- Objectives: This study evaluates whether strict BP management is useful for the prevention of recurrent stroke. Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group and less stricter BP target <140/90 mmHg or <130/80 mmHg for patients with current DM/CKD/MI in the standard BP control group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 330 between the two groups. The occurrence rates of recurrent stroke will be compared between the two groups.
- Hypotheses The incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: <120/80 mmHg* than in a standard BP control group having BP target <140/90 mmHg or <130/80 mmHg for current DM/CKD/MI in patients with hypertension.
- Study design This will be a multicenter, randomized, open-label study. The study consists of a screening period, a titration period and a follow-up period. The screening period is a period between the date of consent and the enrollment date. Hypertensive patients with history of stroke are randomly assigned to either the strict BP control group having the target of <120/80 mmHg or the standard BP control group having the target of <140/90 mmHg without current DM, CKD or MI and <130/80 mmHg with current DM, CKD or MI. The titration period is the period finding a treatment which achieves target BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and aldosterone antagonist. The participants will be observed under the BP management for their respective BP target. The study will be continued until the number of patients with the first recurrent stroke reaches a total of 330 between two groups. The follow-up period will be 3 years.
The recurrent rates of stroke in both groups will be compared from various aspects, and strict BP management will be investigated on the usefulness in prevention of recurrent stroke.
Read the detailed description
Rationale for Study Duration Predicting that strict BP control reduces the relative risk of recurrent stroke by 30% during the planned observation period of 3 years, the number of participants necessary to detect the recurrent stroke with rate of 2.5%/year and 7.5%/3 years is 2482 patients per group with a detection power of 90% and α-error of 0.05. A drop-out rate is estimated as 20%.
Therefore, the study will be continued for 3 years until a total of 330 patients with recurrent stroke in both groups are identified.
Rationale for Dosing Regimen One of ARB, losartan, is chosen for Step 1 therapy, because angiotensin II receptor blocker (ARB) is preferred as the first line of anti-hypertensives. Furthermore, a stepwise combination therapy of BP lowering drugs diuretic, hydrochlorothiazide, and calcium channel blocker, amlodipine, will be used, because the Japanese guidelines recommend the combination for BP control in prevention of recurrent stroke. (Step 2 to Step 5). Finally (as Step 6), a selective aldosterone antagonist, spironolactone, will be added for the treatment of with refractory hypertensive patients whose BP does not reach to the target.
Treatment Plan The dosages of study drugs will be determined according to the package insert for the drug.
Patients who are not treated with antihypertensive agent or treated with one antihypertensive agent at enrollment will start from Step 1. Patients who are treated with two antihypertensive agents at enrollment will start from Step 2.
In principle, treatment duration will be for 4 weeks at each step.
- Conditions
- Hypertension, Stroke, Blood Pressure
- Being tested
- Losartan, Losartan and HCTZ, Amlodipine , Spironolactone
- Keywords
- hypertension, stroke, blood pressure
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan, Losartan and HCTZ, Amlodipine , SpironolactoneDrug
Also called candesartan cilexetil, valsartan, telmisartan, olmesartan medoxomil
<Study drugs and treatment steps> Step 1: Losartan 50 mg in principle (other ARB is usable) Step 2: Combination drug containing losartan 50 mg and hydrochlorothiazide 12.5 mg Step 3: Combination drug containing losartan 50mg and HCTZ 12.5mg + amlodipine 5 mg Step 4: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 5 mg Step 5: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg Step 6: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg + spironolactone 25 mg
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure | Experimental | The incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: less than 120/80 mmHg* than in a standard BP control group having BP target less than 140/90 mmHg or less than 130/80 mmHg for current DM/CKD/old MI in patients with hypertension.
* This study uses BP target: less than 120/80 mmHg that is sat up for this study rather than the BP target recommended in the Guidelines for the management of hypertension, Japanese Society of Hypertension 2009.
* BP management is strongly recommended in patients with hypertension, DM, and/or CKD for prevention of recurrent stroke in the Japanese guidelines for the management of stroke 2009. Receives: Drug: Losartan, Losartan and HCTZ, Amlodipine , Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevention of recurrent stroke.
Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve BP target less than 120/80 mmHg in the strict BP group and BP target less than 140/90 mmHg or less than 130/80 mmHg for patients with DM/CKD/old MI in the standard BP group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 339 between the two groups.
Measured: Until the first recurrent stroke reaches a total of 339 between the two groups
Secondary outcomes (1)
The incidence of events other than stroke
Under the strict BP control, not only the recurrence of stroke but also occurrence of cardiovascular events (such as myocardial infarction and heart failure), angioplasty, and death will be reduced.
Separate hypothesis: Additionally, occurrence and exacerbation of dementia is also decreased under the strict BP control in comparison with the standard control.
Measured: Until the first recurrent stroke reaches a total of 339 between the two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedis International Ltd.
- Sponsor type
- University, hospital or other
- Investigators
- Kazuyuki Shimada, MD, Study chair, RESPECT Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198496
- Sponsor's protocol ID
- RESPECT 1
- Other IDs
- UMIN000002851
- Acronym
- RESPECTS
- Status last verified
- Sep 2010
- First submitted
- 28 Aug 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
PubMed 32905623Kitagawa K, Yamamoto Y, Arima H, Maeda T, Sunami N, Kanzawa T, Eguchi K, Kamiyama K, Minematsu K, Ueda S, Rakugi H, Ohya Y, Kohro T, Yonemoto K, Okada Y, Higaki J, Tanahashi N, Kimura G, Umemura S, Matsumoto M, Shimamoto K, Ito S, Saruta T, Shimada K; Recurrent Stroke Prevention Clinical Outcome (RESPECT) Study Group. Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke: A Randomized Clinical Trial and Meta-analysis. JAMA Neurol. 2019 Nov 1;76(11):1309-1318. doi: 10.1001/jamaneurol.2019.2167.
PubMed 31355878
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study for Effect of Intensive Blood-Pressure Control Using Anti-hypertensive Agents in Essential Hypertension With History of Stroke
- ClinicalTrials.gov ID
- NCT01198496
- Acronym / sponsor ID
- RESPECTS / RESPECT 1
- Conditions
- Hypertension, Stroke, Blood Pressure
- Keywords
- hypertension, stroke, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Biomedis International Ltd.University, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Sep 2010 (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.
- Objectives and Hypothesis
- Objectives: This study evaluates whether strict BP management is useful for the prevention of recurrent stroke. Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group and less stricter BP target <140/90 mmHg or <130/80 mmHg for patients with current DM/CKD/MI in the standard BP control group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 330 between the two groups. The occurrence rates of recurrent stroke will be compared between the two groups.
- Hypotheses The incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: <120/80 mmHg* than in a standard BP control group having BP target <140/90 mmHg or <130/80 mmHg for current DM/CKD/MI in patients with hypertension.
- Study design This will be a multicenter, randomized, open-label study. The study consists of a screening period, a titration period and a follow-up period. The screening period is a period between the date of consent and the enrollment date. Hypertensive patients with history of stroke are randomly assigned to either the strict BP control group having the target of <120/80 mmHg or the standard BP control group having the target of <140/90 mmHg without current DM, CKD or MI and <130/80 mmHg with current DM, CKD or MI. The titration period is the period finding a treatment which achieves target BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and aldosterone antagonist. The participants will be observed under the BP management for their respective BP target. The study will be continued until the number of patients with the first recurrent stroke reaches a total of 330 between two groups. The follow-up period will be 3 years.
The recurrent rates of stroke in both groups will be compared from various aspects, and strict BP management will be investigated on the usefulness in prevention of recurrent stroke.
Detailed description
Rationale for Study Duration Predicting that strict BP control reduces the relative risk of recurrent stroke by 30% during the planned observation period of 3 years, the number of participants necessary to detect the recurrent stroke with rate of 2.5%/year and 7.5%/3 years is 2482 patients per group with a detection power of 90% and α-error of 0.05. A drop-out rate is estimated as 20%.
Therefore, the study will be continued for 3 years until a total of 330 patients with recurrent stroke in both groups are identified.
Rationale for Dosing Regimen One of ARB, losartan, is chosen for Step 1 therapy, because angiotensin II receptor blocker (ARB) is preferred as the first line of anti-hypertensives. Furthermore, a stepwise combination therapy of BP lowering drugs diuretic, hydrochlorothiazide, and calcium channel blocker, amlodipine, will be used, because the Japanese guidelines recommend the combination for BP control in prevention of recurrent stroke. (Step 2 to Step 5). Finally (as Step 6), a selective aldosterone antagonist, spironolactone, will be added for the treatment of with refractory hypertensive patients whose BP does not reach to the target.
Treatment Plan The dosages of study drugs will be determined according to the package insert for the drug.
Patients who are not treated with antihypertensive agent or treated with one antihypertensive agent at enrollment will start from Step 1. Patients who are treated with two antihypertensive agents at enrollment will start from Step 2.
In principle, treatment duration will be for 4 weeks at each step.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood pressure | Experimental | Drug: Losartan, Losartan and HCTZ, Amlodipine , SpironolactoneThe incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: less than 120/80 mmHg* than in a standard BP control group having BP target less than 140/90 mmHg or less than 130/80 mmHg for current DM/CKD/old MI in patients with hypertension. * This study uses BP target: less than 120/80 mmHg that is sat up for this study rather than the BP target recommended in the Guidelines for the management of hypertension, Japanese Society of Hypertension 2009. * BP management is strongly recommended in patients with hypertension, DM, and/or CKD for prevention of recurrent stroke in the Japanese guidelines for the management of stroke 2009. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants include those with essential hypertension and history of stroke who satisfy the following criteria:
- Outpatient
- Onset of stroke(cerebral infarction/cerebral hemorrhage) occurred between 30 days and 3 years prior to the date of consent.
- Drug adherence is ≧80% during the screening period.
- Mean of 2 baseline BP measurements(measured at outpatient clinic) within 30 days prior to the date of consent is either 180 >SBP ≧130 mmHg or 110 >DBP ≧80 mmHg (untreated -3 anti hypertensive agents patients).
Key exclusion criteria (19 listed)
- Patient who meets any one of the following criteria is excluded from the study.
- Women who are pregnant, are possible pregnant, or are breastfeeding
- Possible secondary hypertension
- Severe hypertension (grade III or greater) with baseline SBP ≧180 mmHg or DBP ≧110 mmHg)
- Myocardial infarction or undergoing angioplasty occurred within 3 months prior to the screening.
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, Losartan and HCTZ, Amlodipine , SpironolactoneAlso: candesartan cilexetil, valsartan, telmisartan, olmesartan medoxomil<Study drugs and treatment steps> Step 1: Losartan 50 mg in principle (other ARB is usable) Step 2: Combination drug containing losartan 50 mg and hydrochlorothiazide 12.5 mg Step 3: Combination drug containing losartan 50mg and HCTZ 12.5mg + amlodipine 5 mg Step 4: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 5 mg Step 5: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg Step 6: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg + spironolactone 25 mg | Drug | Blood pressure |
Primary outcome
the prevention of recurrent stroke.
Time frame: Until the first recurrent stroke reaches a total of 339 between the two groups
Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve BP target less than 120/80 mmHg in the strict BP group and BP target less than 140/90 mmHg or less than 130/80 mmHg for patients with DM/CKD/old MI in the standard BP group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 339 between the two groups.
1 secondary outcome
The incidence of events other than stroke
Time frame: Until the first recurrent stroke reaches a total of 339 between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
- Derived from this study: PubMed 32905623Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
- Derived from this study: PubMed 31355878Kitagawa K, Yamamoto Y, Arima H, Maeda T, Sunami N, Kanzawa T, Eguchi K, Kamiyama K, Minematsu K, Ueda S, Rakugi H, Ohya Y, Kohro T, Yonemoto K, Okada Y, Higaki J, Tanahashi N, Kimura G, Umemura S, Matsumoto M, Shimamoto K, Ito S, Saruta T, Shimada K; Recurrent Stroke Prevention Clinical Outcome (RESPECT) Study Group. Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke: A Randomized Clinical Trial and Meta-analysis. JAMA Neurol. 2019 Nov 1;76(11):1309-1318. doi: 10.1001/jamaneurol.2019.2167.
- RESPECT StudyLink provided by the sponsor.
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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.
Kazuyuki Shimada, MD study chair
RESPECT Study Group
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, Losartan and HCTZ, Amlodipine , Spironolactone in people with Hypertension and Stroke, run by Biomedis International Ltd. 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 6 inclusion and 19 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 31 Jul 2012. 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?
Contact Hiroko Usami, PhD (81-1-3-6252-3282, hiroko-u@biomedis.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevention of recurrent stroke. (time frame: Until the first recurrent stroke reaches a total of 339 between the two groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01198496, which also lists 3 linked publications.
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 31 Jul 2012.