NCT00090103已完成3 期
A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,844
- 试验地点
- 1
- 主要终点
- Number of Participants With AUR or BPH-related Surgery
研究概览
简要总结
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
详细描述
A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •total serum PSA >10.0ng/mL at Screening
- •history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
- •Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.
- •previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
- •history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
- •history of AUR within 3 months prior to Screening Visit.
- •post-void residual volume >250mL (suprapubic ultrasound) at Screening.
- •any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
- •history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
- •use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
- •concurrent use of anabolic steroids
- •use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
- •use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.
- •Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.
- •use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
- •hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
- •concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
- •history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
- •history of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening.
- •prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
- •history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
- •any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
- •history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
- •history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
- •history of unsuccessful treatment with finasteride or dutasteride
- •history or current evidence of drug or alcohol abuse within the previous 12 months.
- •participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.
研究组 & 干预措施
dutasteride
Active Comparator
dutasteride 0.5mg once daily
干预措施: dutasteride 0.5mg once daily for 4 years (Drug)
Combo
Experimental
Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily
干预措施: dutasteride 0.5mg once daily for 4 years (Drug)
Combo
Experimental
Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily
干预措施: tamsulosin 0.4mg once daily for 4 years (Drug)
tamsulosin
Active Comparator
tamsulosin 0.4mg once daily
干预措施: tamsulosin 0.4mg once daily for 4 years (Drug)
结局指标
主要结局
Number of Participants With AUR or BPH-related Surgery
时间窗: Baseline (Day 1) through Year 4
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
时间窗: Years 1, 2, 3, and 4
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.
次要结局
- Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4(Years 1, 2, 3, and 4)
- Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria(Baseline (Day 1) through Year 4)
- Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, and 48)
- Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, and 48)
- Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, and 48)
- Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit(Every 3 months from Month 3 to Month 48)
- The Number of Participants With Each of the Five Components of BPH Clinical Progression(Baseline (Day 1) to Year 4)
- Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, and 48)
- Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Number of Events of Symptom Deterioration at the Indicated Time Periods(Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit))
- Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit(Every 3 months from Month 3 to Month 48)
- Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.(Every 3 months from Month 3 to Month 48)
- Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"(Every 3 months from Month 3 to Month 48)
- Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)(Every 3 months from Month 3 to Month 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Number of Participants With an Event of Post-baseline BPH-related Hematospermia(Baseline (Day 1) through Year 4)
- Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)(Every 3 months from Month 3 to Month 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)(Baseline and Months 12, 24, 36, and 48)
- Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)(Baseline and Months 12, 24, 36, and 48)
研究者
研究点 (1)
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