CTRI/2021/09/036299已完成4 期
A prospective, open-label, multi-center, single-arm, postmarketing study to evaluate the safety and efficacy of fixed dosecombination of Silodosin and Dutasteride in men with benignprostatic hyperplasia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Male subjects of age 45 or above with current diagnosis of benign prostatic hyperplasia.
- •2. International prostate symptom score (IPSS) at presentation > 7.
- •3. Able to provide written informed consent and to comply with all study procedures.
排除标准
- •1. History of clinically significant (as determined by the investigator) cardiac,
- •endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,
- •immunologic disease, or other major uncontrolled disease.
- •2. Patients with Prostate-Specific Antigen (PSA) level > 4.0ng/mL
- •3. History of allergy to any component of the IP.
- •4. Patients with a residual urinary volume of ââ?°Â¥250 ml.
- •5. Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)].
- •6. Patients with severe hepatic impairment.
- •7. Subjects taking strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole,
- •clarithromycin, itraconazole, ritonavir).
- •8. Hypersensitivity to Ã?±1A-receptor blockers and 5 alpha-reductase inhibitors.
- •9. Presence of a condition or abnormality that in the opinion of the investigator would
- •compromise the safety of the patient or the quality of the data.
研究者
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