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Rationale and Design for Shiga Microalbuminuria Reduction Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Shiga University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shiga University
ClinicalTrials.gov Identifier:
NCT00202618
First received: September 12, 2005
Last updated: April 27, 2006
Last verified: July 2005
  Purpose

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 Intervention Phase
Hypertension
Diabetes Mellitus
Albuminuria
Drug: Valsartan
Drug: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Shiga University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 160
Study Start Date: December 2003
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202618

Contacts
Contact: Atsunori Kashiwagi, Professor 81-77-548-2221 kasiwagi@belle.shiga-med.ac.jp
Contact: Hiroshi Maegawa, A. Professor 81-77-548-2222 maegawa@belle.shiga-med.ac.jp

Locations
Japan
Shiga University of Medical Science Recruiting
Otsu, Shiga, Japan, 520-2192
Contact: Atsunori Kashiwagi, Professor    81-77-548-2221    kasiwagi@belle.shiga-med.ac.jp   
Contact: Hiroshi Maegawa, A. Professor    81-77-548-2222    maegawa@belle.shiga-med.ac.jp   
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
Investigators
Study Chair: Atsunori Kashiwagi, Professor Shiga University of Medical Science
  More Information

No publications provided by Shiga University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00202618     History of Changes
Other Study ID Numbers: SMART001
Study First Received: September 12, 2005
Last Updated: April 27, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Shiga University:
Hypertension
Type 2 diabetes mellitus
Microalbuminuria
Amlodipine
Calcium channel blocker
Valsartan
Angiotensin type 2 receptor blocker

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Vascular Diseases
Amlodipine
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 23, 2014