NCT00202618

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Dec 2003

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 27, 2006

Status Verified

July 1, 2005

First QC Date

September 12, 2005

Last Update Submit

April 27, 2006

Conditions

HypertensionDiabetes MellitusAlbuminuria

Keywords

HypertensionType 2 diabetes mellitusMicroalbuminuriaAmlodipineCalcium channel blockerValsartanAngiotensin type 2 receptor blocker

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

ValsartanDRUG
AmlodipineDRUG

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiga University of Medical Science

Ōtsu, Shiga, 520-2192, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18716365DERIVED

MeSH Terms

Conditions

HypertensionDiabetes MellitusAlbuminuriaDiabetes Mellitus, Type 2

Interventions

ValsartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDihydropyridinesPyridines

Study Officials

  • Atsunori Kashiwagi, Professor

    Shiga University of Medical Science

    STUDY CHAIR

Central Study Contacts

Atsunori Kashiwagi, Professor

CONTACT

81-77-548-2221kasiwagi@belle.shiga-med.ac.jp

Hiroshi Maegawa, A. Professor

CONTACT

81-77-548-2222maegawa@belle.shiga-med.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

December 1, 2003

Study Completion

June 1, 2006

Last Updated

April 27, 2006

Record last verified: 2005-07

Locations

JP(1)