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| Sponsored by: |
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 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
aspirin enalapril microalbuminuria glomerular filtration rate |
|
Albuminuria Metabolic Diseases Urination Disorders Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Enalapril Proteinuria |
Enalaprilat Urologic Diseases Aspirin Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Urological Manifestations |
Fibrin Modulating Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
