EUCTR2006-004378-28-LV进行中（未招募）不适用
A MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO CONTROLLED PROOF OF CONCEPT AND DOSE RANGING STUDY WITH AN ACTIVE CONTROL TO ASSESS THE EFFICACY AND SAFETY/TOLERABILITY OF UK-369,003 IMMEDIATE RELEASE (IR) AND MODIFIED RELEASE (MR) IN THE TREATMENT OF MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) WITH AND WITHOUT ERECTILE DYSFUNCTION (ED)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Ltd
- 入组人数
- 414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) =13 at both visit 1 (screening) and visit 3 (baseline).
- •2. Clinical diagnosis of BPH.
- •3. Qmax 5 to 15ml/sec with a voided volume of =150ml at visit 1 (screening).
- •4. Stable sexual partner for the duration of the trial.
- •5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspectsof the trial.
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests and other trial procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History, evidence or suspicion of prostate cancer (includes total Prostate Specific Antigen (PSA) value > 10 ng/ml unless prostate cancer previously excluded by biopsy) at visit 1 (screening) or during the course of the trial.
- •2. Post-void residual urine volume >200ml based on bladder ultrasound at visit 1
- •(screening).
- •3. Documented urinary tract infection (UTI) at visit 1 (screening) or visit 3 (baseline);
- •subjects with a positive (1+ or greater) leukocyte or nitrite result in urine dipstick test will be excluded unless UTI can be ruled out via urine culture.
- •4. Greater than 1+ of hematuria on dipstick test at visit 1 (screening), unless fully
- •investigated prior to randomization at visit 3 (baseline) to rule out significant urological disease.
- •5. History of relevant urological surgery or procedures that may contribute to LUTS
- •6. Chronic persistent local lower urinary tract pathology
- •7. Known primary neurological conditions such as multiple sclerosis, Parkinson’s disease, or other neurological diseases known to affect bladder function.
- •8. History of catheterization for outflow obstruction in the previous 12 months prior to visit 1 (screening) or visit 3 (baseline).
- •9. Subjects receiving or who are likely to receive any of the following medications or
- •treatments during the trial period.
- •a. a-blockers, muscarinic receptor antagonists, PDE5 inhibitors, and agents known to
- •affect vesico-urethral function or erectile function
- •b. 5-a-RIs such as dutasteride and finasteride
- •c. Diuretics, beta-blockers or other anti-hypertensive agents
- •d. Nitrates or nitric oxide donors in any form on either regular or intermittent basis
- •e. Potent CYP3A4 inhibitors. Topical agents are permitted.
- •f. Warfarin.
- •10. Significant allergy to or known hypersensitivity or intolerance to a-blockers or PDE5 inhibitors.
- •11. Increased susceptibility to vasodilators including those subjects with left ventricular outflow obstruction (e.g., hypertrophic obstructive cardiomyopathy).
- •12. Poorly controlled type I or type II diabetes mellitus as defined by HbA1C >7% at visit 1 (screening).
- •13. Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION)
- •regardless of whether or not this event was temporarily associated with the use of a PDE5 inhibitor.
- •14. Hereditary degenerative retinal disorders (e.g. retinitis pigmentosa).
- •15. History of recurrent syncope or evidence of low blood pressure (BP) (<90mmHg systolic or <40mmHg diastolic) or evidence of symptomatic postural hypotension. This includes relevant postural symptoms associated with fall in systolic BP of > 20 mmHg or diastolic BP > 10 mmHg on standing at visit 1(screening) or visit 3 (baseline).
- •16. Any relevant clinically significant abnormalities on visit 1 (screening) physical
- •examination or laboratory tests including subjects with moderate liver function tests
- •abnormalities (see Appendix 8) and renal function abnormalities (serum creatinine =2.5 mg/dl or =220 µmol/l).
- •17. Family history of prolonged QT syndrome or who themselves have a QTc of >450 msec at visit 1 (screening) as measured by a 12-lead supine ECG.
- •18. Risk of priapism e.g. sickle cell disease, multiple myeloma and myeloproliferative
- •disorders (e.g. myeloid leukemia, polycythemia, thrombocythemia).
- •19. Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the trial, or to comply with the requirements of the protocol, including: dermatologic disease,
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