Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Rationale and Design for Shiga Microalbuminuria Reduction Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202618
Recruitment Status : Unknown
Verified July 2005 by Shiga University.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : April 27, 2006
Information provided by:
Shiga University

Brief 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 control, and to compare the additional effects of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor treatment.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus Albuminuria Drug: Valsartan Drug: Amlodipine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2003
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. A change in the rate of urinary albumin excretion (UAE) from the baseline to the end of study
  2. A normalization of microalbuminuria (normoalbuminuria)
  3. A 50% reduction in UAE from the baseline

Secondary Outcome Measures :
  1. A change in urinary type IV collagen from the baseline to the end of the intervention period
  2. A change in high sensitivity C-reactive protein (hsCRP) from the baseline to the end of the intervention period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypertensive patient with type 2 diabetes
  • Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202618

Layout table for location contacts
Contact: Atsunori Kashiwagi, Professor 81-77-548-2221
Contact: Hiroshi Maegawa, A. Professor 81-77-548-2222

Layout table for location information
Shiga University of Medical Science Recruiting
Otsu, Shiga, Japan, 520-2192
Contact: Atsunori Kashiwagi, Professor    81-77-548-2221   
Contact: Hiroshi Maegawa, A. Professor    81-77-548-2222   
Principal Investigator: Hiroshi Maegawa         
Principal Investigator: Yasuo Kida         
Principal Investigator: Shu Yamada         
Principal Investigator: Masataka Nishimura         
Principal Investigator: Tetsuro Arimura         
Principal Investigator: Noriko Takahara         
Principal Investigator: Katsuya Egawa         
Principal Investigator: Masanori Iwanishi         
Principal Investigator: Toshiki Fujita         
Principal Investigator: Aya Kadota         
Sponsors and Collaborators
Shiga University
Layout table for investigator information
Study Chair: Atsunori Kashiwagi, Professor Shiga University of Medical Science
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00202618    
Other Study ID Numbers: SMART001
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 27, 2006
Last Verified: July 2005
Keywords provided by Shiga University:
Type 2 diabetes mellitus
Calcium channel blocker
Angiotensin type 2 receptor blocker
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists