KCT0001049
Completed
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yuhan
- Enrollment
- 112
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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