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Sponsored by: |
Shiga University |
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Information provided by: | Shiga University |
ClinicalTrials.gov Identifier: | NCT00202618 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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) |
Estimated Enrollment: | 160 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Japan, Shiga | |
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 |
Study Chair: | Atsunori Kashiwagi, Professor | Shiga University of Medical Science |
Study ID Numbers: | SMART001 |
Study First Received: | September 12, 2005 |
Last Updated: | April 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00202618 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Hypertension Type 2 diabetes mellitus Microalbuminuria Amlodipine |
Calcium channel blocker Valsartan Angiotensin type 2 receptor blocker |
Vasodilator Agents Albuminuria Metabolic Diseases Urination Disorders Diabetes Mellitus Vascular Diseases Calcium Channel Blockers Endocrine System Diseases Cardiovascular Agents Antihypertensive Agents Amlodipine |
Calcium, Dietary Signs and Symptoms Proteinuria Urologic Diseases Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Valsartan Hypertension |
Vasodilator Agents Albuminuria Metabolic Diseases Molecular Mechanisms of Pharmacological Action Urination Disorders Diabetes Mellitus Vascular Diseases Calcium Channel Blockers Endocrine System Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Amlodipine Membrane Transport Modulators Urological Manifestations Signs and Symptoms Proteinuria Urologic Diseases Therapeutic Uses Diabetes Mellitus, Type 2 Cardiovascular Diseases Glucose Metabolism Disorders Valsartan Hypertension |