A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia
Abstract
No AccessJournal of UrologyClinical Urology: Original Articles1 Nov 1998A SECOND PHASE III MULTICENTER PLACEBO CONTROLLED STUDY OF 2 DOSAGES OF MODIFIED RELEASE TAMSULOSIN IN PATIENTS WITH SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA PERINCHERY NARAYAN and ASHUTOSH TEWARI PERINCHERY NARAYANPERINCHERY NARAYAN More articles by this author and ASHUTOSH TEWARIASHUTOSH TEWARI More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)62386-3AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: In a double-blind, phase III clinical trial we evaluate the safety and efficacy of 0.4 and 0.8 mg. tamsulosin daily for the treatment of patients with symptoms of moderate to severe benign prostatic hyperplasia. Materials and Methods: Patients meeting the basic requirements of the study underwent a 4-week single-blind placebo evaluation period. A total of 735 patients were randomized to double-blind therapy with tamsulosin or placebo. Treatment duration was 13 weeks. Efficacy and safety were evaluated at 5 visits during the double-blind treatment period. Results: When efficacy data between baseline and end point were compared there was a significant reduction in total American Urological Association symptom score (25%) in each tamsulosin group compared with placebo (p = 0.01) and the percentage of patients with a 30% or more reduction in peak urinary flow rate was…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 735 participants or records.
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