HypertensionPhase 4NCT00202618
Rationale and Design for Shiga Microalbuminuria Reduction Trial
A Phase 4 study testing Valsartan and Amlodipine in people with Hypertension and Diabetes Mellitus, run by Shiga University at 1 site in Japan.
Trial summary
The purpose of this trial are to evaluate the reduction of urinary albumin excretion by an angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria under strict blood pressure… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Albuminuria
- What is being tested?
- Valsartan and Amlodipine
- How many people
- 160 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2003to Jun 2006
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patient with type 2 diabetes
- Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr
Who cannot join
- Type 1 diabetes mellitus
- Pregnant women and women of childbearing potential
- Severe hypertension (> 180/110 mmHg), malignant hypertension, secondary hypertension
- History of cardiovascular diseases in the preceding 6 months (including symptomatic heart failure, unstable angina, myocardial infarction, the performance of percutaneous transluminal coronary angioplasty [PTCA], or coronary artery bypass graft [CABG], severe arrhythmia, or second or third degree atrioventricular [AV] block)
- History of clinically significant valvular disease (e.g., aortic stenosis, mitral insufficiency)
- History of cerebral infarction, cerebral hemorrhage, or transient ischemic attack
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- Serum creatinine level >1.5 mg/dl
- Persistent hematuria
- Serum potassium > 5.6 mEq/L (hyperkalemia)
- Severe hepatic disorder (e.g., hepatic failure, hepatic cirrhosis)
- Complication of an allergy of potential clinical concern
- Hypersensitivity to ARBs or CCBs
- Gastrointestinal surgery or gastrointestinal disorders which could interfere with drug absorption
- Autoimmune disease
- Participation in any intervention trial within 3 months prior to the observation period
- Patients who are unwilling or unable to comply with the trial protocol
- Concomitant use of other ARBs, CCBs, or potassium-retaining diuretics
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Shiga University of Medical Science
Ōtsu, Shiga, 520-2192
Atsunori Kashiwagi, Professor, 81-77-548-2221, kasiwagi@belle.shiga-med.ac.jp
Hiroshi Maegawa, A. Professor, 81-77-548-2222, maegawa@belle.shiga-med.ac.jp
About this study
Official title: The Reduction of Microalbuminuria in Japanese Hypertensive Subjects With Type 2 Diabetes Mellitus Treated With Valsartan or Amlodipine: Study Design for the Shiga Microalbuminuria Reduction Trial (SMART)
The purpose of this trial are to evaluate the reduction of urinary albumin excretion by an angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria under strict blood pressure control, and to compare the additional effects of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor treatment.
Read the detailed description
Microalbuminuria in diabetic patients is an established risk marker for the progression of diabetic nephropathy and for cardiovascular mortality. Intervention trials have demonstrated that drugs that blockade the renin-angiotensin system can reduce microalbuminuria in Caucasian patients with type 2 diabetes mellitus and microalbuminuria, regardless of blood pressure level. However, it remains uncertain whether angiotensin receptor blockers or calcium channel blockers give a greater reduction of microalbuminuria. The Shiga Microalbuminuria Reduction Trial (SMART) is a prospective, multicentre, randomized, active-controlled, two-arm parallel treatment group comparison study aimed at evaluating reduction of microalbuminuria in 160 Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria. The trial consists of an 8-week observation period for screening and washout, and a 24-week intervention period. After the observation period, patients are randomized to either amlodipine 5 mg once daily or valsartan 80 mg once daily as an initial dose. After four weeks, if patients cannot achieve the target blood pressure (<130/80 mmHg) with the initial dose of a study drug, doses are titrated up to amlodipine 10 mg once daily or valsartan 160 mg once daily. The primary endpoints are a change in the rate of urinary albumin excretion from baseline, a normalization of microalbuminuria, and a 50% reduction in urinary albumin excretion from baseline, which are compared between treatment groups. This study will provide additional data for the treatment of hypertension and microalbuminuria and has important health care implications for Japanese patients with type 2 diabetes.
- Conditions
- Hypertension, Diabetes Mellitus, Albuminuria
- Being tested
- Valsartan, Amlodipine
- Keywords
- Hypertension, Type 2 diabetes mellitus, Microalbuminuria, Amlodipine, Calcium channel blocker, Valsartan, Angiotensin type 2 receptor blocker
- Medical subject headings
- Hypertension, Diabetes Mellitus, Albuminuria, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
AmlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in the rate of urinary albumin excretion (UAE) from the baseline to the end of study
A normalization of microalbuminuria (normoalbuminuria)
A 50% reduction in UAE from the baseline
Secondary outcomes (2)
A change in urinary type IV collagen from the baseline to the end of the intervention period
A change in high sensitivity C-reactive protein (hsCRP) from the baseline to the end of the intervention period
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 startDec 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 160 participants
Sponsor and investigators
- Lead sponsor
- Shiga University
- Sponsor type
- University, hospital or other
- Investigators
- Atsunori Kashiwagi, Professor, Study chair, Shiga University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202618
- Sponsor's protocol ID
- SMART001
- Status last verified
- Jul 2005
- First submitted
- 12 Sep 2005
- Last updated
- 27 Apr 2006
- Results posted
- No
Publications
Shiga Microalbuminuria Reduction Trial (SMART) Group; Uzu T, Sawaguchi M, Maegawa H, Kashiwagi A. Impact of renin-angiotensin system inhibition on microalbuminuria in type 2 diabetes: a post hoc analysis of the Shiga Microalbuminuria Reduction Trial (SMART). Hypertens Res. 2008 Jun;31(6):1171-6. doi: 10.1291/hypres.31.1171.
PubMed 18716365
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reduction of Microalbuminuria in Japanese Hypertensive Subjects With Type 2 Diabetes Mellitus Treated With Valsartan or Amlodipine: Study Design for the Shiga Microalbuminuria Reduction Trial (SMART)
- ClinicalTrials.gov ID
- NCT00202618
- Acronym / sponsor ID
- SMART001
- Conditions
- Hypertension, Diabetes Mellitus, Albuminuria
- Keywords
- Hypertension, Type 2 diabetes mellitus, Microalbuminuria, Amlodipine, Calcium channel blocker, Valsartan, Angiotensin type 2 receptor blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants
- Lead sponsor
- Shiga UniversityUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Jun 2006
- 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 purpose of this trial are to evaluate the reduction of urinary albumin excretion by an angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria under strict blood pressure control, and to compare the additional effects of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor treatment.
Detailed description
Microalbuminuria in diabetic patients is an established risk marker for the progression of diabetic nephropathy and for cardiovascular mortality. Intervention trials have demonstrated that drugs that blockade the renin-angiotensin system can reduce microalbuminuria in Caucasian patients with type 2 diabetes mellitus and microalbuminuria, regardless of blood pressure level. However, it remains uncertain whether angiotensin receptor blockers or calcium channel blockers give a greater reduction of microalbuminuria. The Shiga Microalbuminuria Reduction Trial (SMART) is a prospective, multicentre, randomized, active-controlled, two-arm parallel treatment group comparison study aimed at evaluating reduction of microalbuminuria in 160 Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria. The trial consists of an 8-week observation period for screening and washout, and a 24-week intervention period. After the observation period, patients are randomized to either amlodipine 5 mg once daily or valsartan 80 mg once daily as an initial dose. After four weeks, if patients cannot achieve the target blood pressure (<130/80 mmHg) with the initial dose of a study drug, doses are titrated up to amlodipine 10 mg once daily or valsartan 160 mg once daily. The primary endpoints are a change in the rate of urinary albumin excretion from baseline, a normalization of microalbuminuria, and a 50% reduction in urinary albumin excretion from baseline, which are compared between treatment groups. This study will provide additional data for the treatment of hypertension and microalbuminuria and has important health care implications for Japanese patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertensive patient with type 2 diabetes
- Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr
Key exclusion criteria (17 listed)
- Type 1 diabetes mellitus
- Pregnant women and women of childbearing potential
- Severe hypertension (> 180/110 mmHg), malignant hypertension, secondary hypertension
- History of cardiovascular diseases in the preceding 6 months (including symptomatic heart failure, unstable angina, myocardial infarction, the performance of percutaneous transluminal coronary angioplasty [PTCA], or coronary artery bypass graft [CABG], severe arrhythmia, or second or third degree atrioventricular [AV] block)
- History of clinically significant valvular disease (e.g., aortic stenosis, mitral insufficiency)
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 |
|---|---|---|
| Valsartan | Drug | – |
| Amlodipine | Drug | – |
Primary outcome
A change in the rate of urinary albumin excretion (UAE) from the baseline to the end of study
A normalization of microalbuminuria (normoalbuminuria)
A 50% reduction in UAE from the baseline
2 secondary outcomes
A change in urinary type IV collagen from the baseline to the end of the intervention period
A change in high sensitivity C-reactive protein (hsCRP) from the baseline to the end of the intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
- Derived from this study: PubMed 18716365Shiga Microalbuminuria Reduction Trial (SMART) Group; Uzu T, Sawaguchi M, Maegawa H, Kashiwagi A. Impact of renin-angiotensin system inhibition on microalbuminuria in type 2 diabetes: a post hoc analysis of the Shiga Microalbuminuria Reduction Trial (SMART). Hypertens Res. 2008 Jun;31(6):1171-6. doi: 10.1291/hypres.31.1171.
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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.
Atsunori Kashiwagi, Professor study chair
Shiga University of Medical Science
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 Diabetes Mellitus, run by Shiga 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 17 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 27 Apr 2006. 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 Atsunori Kashiwagi, Professor (81-77-548-2221, kasiwagi@belle.shiga-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in the rate of urinary albumin excretion (UAE) from the baseline to the end of study. The study lists 3 primary outcomes in all. 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 NCT00202618, which also lists 1 linked publication.
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 27 Apr 2006.