患者様やご家族など一般の方向け臨床・治癒情報サイト　臨床研究情報ポータルサイト

前立腺肥大症に対するデュタステリドからタダラフィルへの切り替え試験（多施設共同・ランダム化・非盲検試験）

基本情報

進捗状況	試験終了
対象疾患	前立腺肥大症
試験開始日（予定日）	2016-01-20
目標症例数	200
臨床研究実施国	日本
研究のタイプ	介入

試験の内容

介入1	Tadalafil 5mg one a day, for 12 weeks
介入2	No treatment, observation for 12 weeks
主要アウトカム評価項目	12週後のIPSSの変化
副次アウトカム評価項目	12週後のIPSSサブスコアの変化，Qmax, 血圧、PSA、テストステロン,IIEF5, 残尿量，酸化ストレスの変化

対象疾患

年齢（下限）
年齢（上限）
性別	1
選択基準	Males, 20 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms who were taking dutasteride Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1. Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
除外基準	Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1. History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1. History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1. Clinical evidence of prostate cancer at Visit 1. Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1. History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil