HypertensionPhase 4ATTEMPT-CVDNCT01075698
A Trial of Telmisartan Prevention of Cardiovascular Disease
A Phase 4 study testing Non-ARB (standard therapy) and ARB (Telmisartan) in people with Hypertension, run by Kumamoto University at 1 site in Japan.
Trial summary
The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Non-ARB (standard therapy) and ARB (Telmisartan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2009to Mar 2016
- 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
None listed.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study.
- Type 1 diabetes mellitus
- Severe renal disorders (serum creatinine of ≥ 2.0 mg/dL)
- Myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation
- Diagnosis of heart failure (NYHA III or IV class )
- Virulent hypertension and secondary hypertension
Show all 11Show fewer
- Pregnant women
- Clinically relevant allergic symptoms or past history of hypersensitivity to drugs / significant adverse drug reactions
- Extremely poor bile secretion or serious liver disorders
- Treatment-required malignant tumors
- Patients who are judged by the physician in charge to be ineligible for the study for any other reasons
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital
Kumamoto, 860-8555
About this study
The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition, onset of cardiovascular events and levels of markers that are associated with cardiovascular events are observed over time to examine the significance of each marker. The biomarkers will be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study.
Read the detailed description
Events are defined as follows; Cerebrovascular events: Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke), transient ischemic attack Coronary events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia Cardiac events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia, heart failure Aortic/peripheral arterial events: Aortic aneurysm, aortic dissection, arteriosclerotic disease (aorta, carotid artery, renal artery, mesenteric artery, peripheral artery, etc.) Complications of diabetes: Diabetic nephropathy*, diabetic retinopathy*, diabetic neuropathy* Aggravation of renal function: Doubling of serum creatinine level, ESRD (initiation of dialysis, renal transplantation)
*Newly occurred or aggravated
The followings will be measured as biomarkers; urinary albumin creatinine rates (UACR), plasma brain natriuretic peptide (BNP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum adiponectin, serum high-molecular weight adiponectin, high sensitivity c-reactive protein (hsCRP), estimated glomerular filtration rate (eGFR)
- Conditions
- Hypertension
- Being tested
- Non-ARB (standard therapy), ARB (Telmisartan)
- Keywords
- Type 2 Diabetes, Cerebrovascular disease, Coronary Artery Disease, Chronic Kidney Disease, Peripheral Artery Disease
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Cerebrovascular Disorders, Coronary Artery Disease, Renal Insufficiency, Chronic, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ARB (standard therapy)Drug
Blood pressure lowering therapy except ARB
ARB (Telmisartan)Drug
Telmisartan 20-80 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Non-ARB group | Active comparator | Not described Receives: Drug: Non-ARB (standard therapy) |
| ARB group | Active comparator | Not described Receives: Drug: ARB (Telmisartan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP)
Measured: for three years
Secondary outcomes (1)
The effect of the two treatments on the incidence of events, and the relationship between the incidence of events and the biomarker levels (UACR, BNP, urine 8-hydroxy-2-deoxyguanosine, serum adiponectin, serum high-molecule adiponectin, eGFR)
Measured: for three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Foundation for Aging and Health
- Responsible party
- Principal investigator, Hirofumi Soejima, Kumamoto University
- Investigators
- Hisao Ogawa, Prof., MD, PhD, Study chair, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto UniversityShokei Kim-Mitsuyama, Prof., MD, PhD, Study director, Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto UniversityKoichi Node, Prof, MD, PhD, Study director, Department of Cardiovascular and Renal Medicine, Saga University Faculty of MedicineHirofumi Soejima, MD, PhD, Principal investigator, Health Care Center / Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto UniversityOsamu Yasuda, MD, PhD, Principal investigator, Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075698
- Sponsor's protocol ID
- H21-1
- Acronym
- ATTEMPT-CVD
- Status last verified
- Sep 2016
- First submitted
- 24 Feb 2010
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ogawa H, Soejima H, Matsui K, Kim-Mitsuyama S, Yasuda O, Node K, Yamamuro M, Yamamoto E, Kataoka K, Jinnouchi H, Sekigami T; ATTEMPT-CVD investigators. A trial of telmisartan prevention of cardiovascular diseases (ATTEMPT-CVD): Biomarker study. Eur J Prev Cardiol. 2016 Jun;23(9):913-21. doi: 10.1177/2047487315603221. Epub 2015 Aug 31.
PubMed 26324672Kim-Mitsuyama S, Soejima H, Yasuda O, Node K, Jinnouchi H, Yamamoto E, Sekigami T, Ogawa H, Matsui K. Reduction in hsCRP levels is associated with decreased incidence of cardiovascular events in Japanese hypertensive women but not in men. Sci Rep. 2020 Oct 12;10(1):17040. doi: 10.1038/s41598-020-73905-4.
PubMed 33046765
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Telmisartan Prevention of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01075698
- Acronym / sponsor ID
- ATTEMPT-CVD / H21-1
- Conditions
- Hypertension
- Keywords
- Type 2 Diabetes, Cerebrovascular disease, Coronary Artery Disease, Chronic Kidney Disease, Peripheral Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Collaborators
- Japan Foundation for Aging and Health
- Study start
- Jul 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Feb 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.
The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition, onset of cardiovascular events and levels of markers that are associated with cardiovascular events are observed over time to examine the significance of each marker. The biomarkers will be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study.
Detailed description
Events are defined as follows; Cerebrovascular events: Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke), transient ischemic attack Coronary events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia Cardiac events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia, heart failure Aortic/peripheral arterial events: Aortic aneurysm, aortic dissection, arteriosclerotic disease (aorta, carotid artery, renal artery, mesenteric artery, peripheral artery, etc.) Complications of diabetes: Diabetic nephropathy*, diabetic retinopathy*, diabetic neuropathy* Aggravation of renal function: Doubling of serum creatinine level, ESRD (initiation of dialysis, renal transplantation)
*Newly occurred or aggravated
The followings will be measured as biomarkers; urinary albumin creatinine rates (UACR), plasma brain natriuretic peptide (BNP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum adiponectin, serum high-molecular weight adiponectin, high sensitivity c-reactive protein (hsCRP), estimated glomerular filtration rate (eGFR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-ARB group | Active comparator | Drug: Non-ARB (standard therapy) |
| ARB group | Active comparator | Drug: ARB (Telmisartan) |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Patients who meet any of the following criteria will be excluded from the study.
- Type 1 diabetes mellitus
- Severe renal disorders (serum creatinine of ≥ 2.0 mg/dL)
- Myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation
- Diagnosis of heart failure (NYHA III or IV class )
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 |
|---|---|---|
| Non-ARB (standard therapy)Blood pressure lowering therapy except ARB | Drug | Non-ARB group |
| ARB (Telmisartan)Telmisartan 20-80 mg/day | Drug | ARB group |
Primary outcome
The effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP)
Time frame: for three years
1 secondary outcome
The effect of the two treatments on the incidence of events, and the relationship between the incidence of events and the biomarker levels (UACR, BNP, urine 8-hydroxy-2-deoxyguanosine, serum adiponectin, serum high-molecule adiponectin, eGFR)
Time frame: for three years
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 7 Sep 2016.
- Background: PubMed 26324672Ogawa H, Soejima H, Matsui K, Kim-Mitsuyama S, Yasuda O, Node K, Yamamuro M, Yamamoto E, Kataoka K, Jinnouchi H, Sekigami T; ATTEMPT-CVD investigators. A trial of telmisartan prevention of cardiovascular diseases (ATTEMPT-CVD): Biomarker study. Eur J Prev Cardiol. 2016 Jun;23(9):913-21. doi: 10.1177/2047487315603221. Epub 2015 Aug 31.
- Derived from this study: PubMed 33046765Kim-Mitsuyama S, Soejima H, Yasuda O, Node K, Jinnouchi H, Yamamoto E, Sekigami T, Ogawa H, Matsui K. Reduction in hsCRP levels is associated with decreased incidence of cardiovascular events in Japanese hypertensive women but not in men. Sci Rep. 2020 Oct 12;10(1):17040. doi: 10.1038/s41598-020-73905-4.
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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.
Hisao Ogawa, Prof., MD, PhD study chair
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Shokei Kim-Mitsuyama, Prof., MD, PhD study director
Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University
Koichi Node, Prof, MD, PhD study director
Department of Cardiovascular and Renal Medicine, Saga University Faculty 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 Non-ARB (standard therapy) and ARB (Telmisartan) in people with Hypertension, run by Kumamoto University 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 0 inclusion and 11 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 7 Sep 2016. 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 effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP) (time frame: for three years). 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 NCT01075698, which also lists 2 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 7 Sep 2016.