Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Dutasteride; Placebo
Intervention description: once daily; once daily
Intervention MeSH terms: Dutasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 378.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia BPH dutasteride

Summary:

      This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52
      weeks to Benign Prostatic Hyperplasia (BPH) patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Only subjects who meet all the following criteria during the screening phase will be
        enrolled in the study.

          1. Diagnosis: BPH

          2. Age: ≥50 years

          3. Gender: Male

          4. Estimated prostate volume ≥30cc (by TRUS)

          5. I-PSS Symptom Score (total of 7 items) ≥8 points

          6. Maximum flow rate (Qmax) ≤15mL/sec (voided volume measured simultaneously ≤150mL)*[1]

          7. Patients who meet either of the following regarding tamsulosin HCl use:

             Patients with tamsulosin HCl use:

             Patients who have received tamsulosin HCl continuously for at least 4 weeks and who
             are likely to continue to take tamsulosin HCl without any change to the dosage and
             administration of the drug until the end of study treatment.

             Patients without tamsulosin HCl use:

             Patients who haven't received tamsulosin HCl in the past 4 weeks and who are unlikely
             to use tamsulosin HCl until the end of study treatment.

          8. Outpatients

          9. Patients who in person have given written consent

        Exclusion Criteria:

        Patients who apply to any of the following criteria during the screening phase will not be
        enrolled in the study.

          1. Post void residual volume >250mL (by suprapubic ultrasound).

          2. History of AUR within the previous 12 weeks.

          3. Evidence or history of prostate cancer.

          4. PSA >10ng/mL [in patients with PSA >4ng/mL, the presence of prostate cancer should be
             ruled out by the investigator/subinvestigator. DRE and free/total PSA ratio should be
             considered, and prostate biopsy be conducted if necessary].

          5. Previous surgery (including balloon dilatation, thermotherapy and stent placement) or
             minimally invasive techniques for BPH.

          6. Any causes other than BPH, which may in the judgment of the
             investigator/subinvestigator, affect evaluation of symptoms or urine flow (e.g.,
             neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy,
             acute/chronic prostatitis, acute/chronic urinary tract infection).

          7. History of any unstable, serious co-existing medical condition(s) including, but not
             limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac
             arrhythmias*[2], congestive heart failure or cerebrovascular accident within the
             previous 6 months; or diabetes mellitus or peptic ulcer uncontrollable with medical
             treatment.

          8. Liver function tests (AST, ALT, AL-P) >2 times the upper limit of normal.

          9. Serum cleatinine >1.8mg/dL.

         10. Use of any antiandrogen (e.g., chlormadinone acetate, allylesterenol) for BPH within
             the previous 12 months.

         11. Use of a1-adrenoceptor blockers excluding tamsulosin HCl (e.g., prazosin HCl, urapidil
             slow-release capsule formulation, terazosin HCl, naftopidil), plant extract
             preparations for treatment of BPH (e.g., Eviprostat, cernitin pollen extract), herbal
             medicines (e.g., hachimi-jio-gan, gosha-jinki-gan), other drugs (e.g., Paraprost), and
             dietary or herbal supplements (e.g., saw palmetto) for relief of BPH symptoms within
             the previous 4 weeks.

        Use of a-adrenoceptor agonists (e.g., pseudoephedrine, phenyle

          -  [1] Subjects with voided volume <150 mL at Qmax measurement cannot be enrolled in the
             study and may undergo re-measurement of Qmax before the visit for Week 0 for study
             entry.

          -  [2] Of "Degree II" according to "Grading of Side Effects (PMSB Notification No. 80
             dated June 29, 1992) or equivalent (Appendix 4).