HypertensionPhase 4NCT00129233
Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance
A Phase 4 study testing Valsartan and Amlodipine in people with Hypertension and Type 2 Diabetes Mellitus, run by Nagoya University at 1 site in Japan.
Trial summary
Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus
- What is being tested?
- Valsartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2004to Apr 2013
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension
- Clinical diagnosis of type 2 diabetes or impaired glucose tolerance
Who cannot join
- History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
- Taking calcium channel blocker for the purpose of angina pectoris
- Reduced ejection fraction (< 40%)
- Second- or third-degree of atrioventricular block
- Severe hypertension (> 200/110 mmHg) or secondary hypertension
- History of stroke in the recent 6 months
Show all 9Show fewer
- Serum creatinine > 2.5 mg/dl
- Estimated survival duration less than 3 years due to other conditions
- Pregnant woman or possibly pregnant woman
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, 466-8550
About this study
Official title: The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Being tested
- Valsartan, Amlodipine
- Keywords
- cardiovascular disease, rennin-angiotensin system, calcium channel blocker, impaired glucose tolerance
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
valsartan 80 to 160 mg daily
AmlodipineDrug
Amlodipine 5 to 10 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Active comparator | Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors. Receives: Drug: Valsartan |
| Amlodipine | Active comparator | Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers. Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death
Measured: At least 3 years of mean follow up period
Secondary outcomes (5)
total death
Measured: At least 3 years of mean follow up period
cardiac function evaluated by ultrasonography
Measured: At least 3 years of mean follow up period
incidence of atrial fibrillation/flutter
Measured: At least 3 years of mean follow up period
control of blood glucose
Measured: At least 3 years of mean follow up period
renal function
Measured: At least 3 years of mean follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2010
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOYOAKI MUROHARA, Nagoya University
- Investigators
- Toyoaki Murohara, MD, PhD, Principal investigator, Department of Cardiology, Nagoya University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129233
- Sponsor's protocol ID
- 169
- Status last verified
- Apr 2013
- First submitted
- 10 Aug 2005
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. doi: 10.1016/S0140-6736(04)16451-9.
PubMed 15207952Yamashita K, Kondo T, Muramatsu T, Matsushita K, Nagahiro T, Maeda K, Shintani S, Murohara T. Effects of valsartan versus amlodipine in diabetic hypertensive patients with or without previous cardiovascular disease. Am J Cardiol. 2013 Dec 1;112(11):1750-6. doi: 10.1016/j.amjcard.2013.07.043. Epub 2013 Sep 13.
PubMed 24035165Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, Ichimiya S, Ohno M, Sone T, Ikeda N, Watarai M, Murohara T; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study. Hypertension. 2012 Mar;59(3):580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226. Epub 2012 Jan 9.
PubMed 22232134Matsushita K, Muramatsu T, Kondo T, Maeda K, Shintani S, Murohara T; NAGOYA HEART Study Group. Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance. J Cardiol. 2010 Jul;56(1):111-7. doi: 10.1016/j.jjcc.2010.03.004. Epub 2010 Apr 20.
PubMed 20409690
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
- ClinicalTrials.gov ID
- NCT00129233
- Acronym / sponsor ID
- 169
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Keywords
- cardiovascular disease, rennin-angiotensin system, calcium channel blocker, impaired glucose tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Aug 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.
Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Active comparator | Drug: ValsartanValsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors. |
| Amlodipine | Active comparator | Drug: AmlodipineAmlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of hypertension
- Clinical diagnosis of type 2 diabetes or impaired glucose tolerance
Key exclusion criteria (9 listed)
- History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
- Taking calcium channel blocker for the purpose of angina pectoris
- Reduced ejection fraction (< 40%)
- Second- or third-degree of atrioventricular block
- Severe hypertension (> 200/110 mmHg) or secondary hypertension
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 |
|---|---|---|
| Valsartanvalsartan 80 to 160 mg daily | Drug | Valsartan |
| AmlodipineAmlodipine 5 to 10 mg daily. | Drug | Amlodipine |
Primary outcome
Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death
Time frame: At least 3 years of mean follow up period
5 secondary outcomes
total death
Time frame: At least 3 years of mean follow up period
cardiac function evaluated by ultrasonography
Time frame: At least 3 years of mean follow up period
incidence of atrial fibrillation/flutter
Time frame: At least 3 years of mean follow up period
control of blood glucose
Time frame: At least 3 years of mean follow up period
renal function
Time frame: At least 3 years of mean follow up period
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 1 May 2013.
- Background: PubMed 15207952Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. doi: 10.1016/S0140-6736(04)16451-9.
- Derived from this study: PubMed 24035165Yamashita K, Kondo T, Muramatsu T, Matsushita K, Nagahiro T, Maeda K, Shintani S, Murohara T. Effects of valsartan versus amlodipine in diabetic hypertensive patients with or without previous cardiovascular disease. Am J Cardiol. 2013 Dec 1;112(11):1750-6. doi: 10.1016/j.amjcard.2013.07.043. Epub 2013 Sep 13.
- Derived from this study: PubMed 22232134Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, Ichimiya S, Ohno M, Sone T, Ikeda N, Watarai M, Murohara T; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study. Hypertension. 2012 Mar;59(3):580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226. Epub 2012 Jan 9.
- Derived from this study: PubMed 20409690Matsushita K, Muramatsu T, Kondo T, Maeda K, Shintani S, Murohara T; NAGOYA HEART Study Group. Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance. J Cardiol. 2010 Jul;56(1):111-7. doi: 10.1016/j.jjcc.2010.03.004. Epub 2010 Apr 20.
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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.
Toyoaki Murohara, MD, PhD principal investigator
Department of Cardiology, Nagoya 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 Valsartan and Amlodipine in people with Hypertension and Type 2 Diabetes Mellitus, run by Nagoya 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 2 inclusion and 9 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 1 May 2013. 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?
Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death (time frame: At least 3 years of mean follow up period). 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 NCT00129233, which also lists 4 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 1 May 2013.