EUCTR2018-003136-72-PL进行中（未招募）1 期
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men with Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH) - Vibegron in Men with OAB for BPH
rovant Sciences GmbH0 个研究点目标入组 300 人开始时间: 2021年9月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
- •2. Is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •3. Has ability to continue to receive a stable dose of BPH treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5-ARI.
- •4. In the opinion of the investigator, is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1. Experienced any SAE in Study URO-901-3005 that was reported as possibly or probably related” to study treatment by the investigator.
- •2. Is using any prohibited medications as detailed in Protocol Section 10.6 (Appendix 7).
- •3. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the
- •investigator.
- •4. Has uncontrolled hypertension (systolic blood pressure of = 180 mmHg and/or diastolic blood pressure of = 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
- •5. Has systolic blood pressures = 160 mmHg but < 180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol.
- •6. Subject has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound
- •the results of the study, interfere with the subject’s ability to comply with study procedures, or make participation in the study not in the subject’s best interest.
- •For the complete list of exclusion criteria please refer to Study Protocol.
研究者
相似试验
尚未招募
3 期
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with Rosacea10014982acne rosaceaNL-OMON42492Cutanea Life Sciences26
进行中（未招募）
1 期
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with RosaceaPapulopustular RosaceaMedDRA version: 19.1 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2015-002921-20-GBCutanea Life Sciences, Inc.300
进行中（未招募）
1 期
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with RosaceaPapulopustular RosaceaMedDRA version: 18.1Level: PTClassification code 10039218Term: RosaceaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2015-002921-20-SECutanea Life Sciences, Inc.300
进行中（未招募）
1 期
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with RosaceaEUCTR2015-002921-20-NLCutanea Life Sciences, Inc.300
进行中（未招募）
1 期
A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.EUCTR2017-004279-30-DESanthera Pharmaceuticals (Switzerland) Limited266