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| Sponsor: | Hospital de Clinicas de Porto Alegre |
|---|---|
| Information provided by: | Hospital de Clinicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT00427271 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Microalbuminuria |
Drug: aspirin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | January 2007 |
Research design: randomized, double-blind, placebo-controlled crossover study Patients: Microalbuminuric (urinary albumin excretion [UAE]30-300 mg/d)type 2 diabetes mellitus patients without ischemic heart disease or peptic ulcer Aim:To evaluate the putative interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients Study protocol:Crossover randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a 6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each period.
Statistical analyses: Bland&Altman analyses for crossover trials.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sandra P Silveiro | 55 51 33325188 | sandrasilveiro@terra.com.br |
| Brazil, RS | |
| Hospital de Clínicas de Porto Aelgre | Recruiting |
| Porto Alegre, RS, Brazil, 900035900 | |
| Contact: Sandra P Silveiro, MD 55 51 33325188 sandrasilveiro@terra.com.br | |
| Principal Investigator: Sandra P Silveiro, MD | |
| Sub-Investigator: Eduardo G Camargo, MD | |
| Study Director: | Eduardo G Camargo | Programa de Pós-graduação em Ciências Médicas: Endocrinologia |
More Information
| Study ID Numbers: | 02-353 |
| Study First Received: | January 26, 2007 |
| Last Updated: | January 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00427271 History of Changes |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
aspirin enalapril microalbuminuria glomerular filtration rate |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Signs and Symptoms Enalapril Fibrin Modulating Agents Aspirin Urologic Diseases Sensory System Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Metabolic Diseases Albuminuria Urination Disorders Cyclooxygenase Inhibitors Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Urological Manifestations Proteinuria Analgesics, Non-Narcotic Diabetes Mellitus, Type 2 |
