Multi-center, Randomized, Double-blind, Placebo/Active-controlled, Phase II clinical trial to Assess the Safety and Efficacy of YHD1023 in Patients with Erectile Dysfunction

Yuhan0 个研究点目标入组 112 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•Male volunteers of aged 20 years and older with history of organic erectile dysfunction of at least 6 months duration
•- Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study
•- The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

•- Have history of stroke, myocardial infarction, or Coronary Artery Bypass Graft surgery within the last 6 months
•- Have history of cardiac failure, unstable angina, or life-threatening arrhythmia within the last 6 months
•- Shown tachyarrhythmia, heart rate over 100 times/min(e.g. arterial fibrillation, flutter)
•- Presence of hypotension as evidenced by SBP/DBP < 90/50mmHg or uncontrollable hypertension as evidenced by SBP/DBP > 170/100mmHg
•- Have history of symptomatic postural hypotension within the last 6 months
•- Have history of spinal cord injury, radical prostatectomy, or pelvic surgery
•- Subject who is judged to be ineligible according to their physical checkup(medical history, physical examination, ECG, laboratory values and etc.) within 56 days prior to the first administration
•- Participated in any other clinical trials within 30 days prior to the first administration
•- Subject who is judged to be ineligible by principal investigator or sub-investigator due to mental disorder or continuous drug abuse

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