NCT00427271

Brief Summary

Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients

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
20

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4 diabetes-mellitus

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

March 1, 2003

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
Last Updated

January 29, 2007

Status Verified

January 1, 2007

First QC Date

January 26, 2007

Last Update Submit

January 26, 2007

Conditions

Diabetes MellitusMicroalbuminuria

Keywords

aspirinenalaprilmicroalbuminuriaglomerular filtration rate

Outcome Measures

Primary Outcomes (2)

  • urinary albumin excretion

  • glomerular filtration rate

Interventions

aspirinDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes mellitus microalbuminuria

You may not qualify if:

  • ischemic heart disease peptic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Aelgre

Porto Alegre, Rio Grande do Sul, 900035900, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Eduardo G Camargo

    Programa de Pós-graduação em Ciências Médicas: Endocrinologia

    STUDY DIRECTOR

Central Study Contacts

Sandra P Silveiro

CONTACT

55 51 33325188sandrasilveiro@terra.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 29, 2007

Study Start

March 1, 2003

Study Completion

January 1, 2007

Last Updated

January 29, 2007

Record last verified: 2007-01

Locations

BR(1)