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Clinical Trial Details

Trial ID: L3492
Source ID: NCT01667614
Associated Drug: Spironolacone 25 Mg Tablets Added To Losartan
Title: Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Diabetic Nephropathy|Essential Hypertension
Interventions: DRUG: spironolacone 25 mg tablets added to losartan
Outcome Measures: Primary: Urinary albumin excretion, Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month., 18 months | Secondary: estimated glomerular filtration rate, estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month., 18 months|Blood pressure, Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month., 18 months|serum creatinine concentrations, serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month., 18 months|Serum potassium concentrations, Serum potassium concentrations measured at baseline, 1st month, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month., 18 months
Sponsor/Collaborators: Sponsor: Tehran University of Medical Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 136
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-05
Completion Date: 2012-07
Results First Posted:
Last Update Posted: 2012-08-28
Locations: Tehran University of Medical Sciences, Vali-asr hospital, Endocrinology and Metabolism Research Center, Tehran, 13145-784, Iran, Islamic Republic of
URL: https://clinicaltrials.gov/show/NCT01667614