EUCTR2005-001627-11-SK
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia - RESTORE
Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V., as of August 2005)0 sites1,051 target enrollmentJuly 25, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- TS (lower urinary tract symptoms) associated with BPH (benign prostatic hyperplasia)
- Sponsor
- Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V., as of August 2005)
- Enrollment
- 1051
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At study entry (visit 1\):
- •1\.Male subject aged 45 years or over
- •2\.Written informed consent has been obtained
- •3\.Diagnosed as having LUTS associated with BPH
- •4\.A total I\-PSS score of greater than / equal to 13
- •5\.A maximum urinary flow rate of greater than / equal to 4\.0 mL/s and less than / equal to 12\.0 mL/s, with a voided volume greater than / equal to 120 ml during free flow (a minimum of 2 flows are to be performed within 3 months of visit 1\)
- •6\.PSA levels are within normal ranges, or if outside of normal ranges are not of clinical significance according to the investigator. A recent PSA value (determined within 3 months of visit 1\) is acceptable. If a recent value is not available, a blood sample should be taken at visit 1 to determine PSA levels.
- •7\.On average, at least 2 voids per night over the last week
- •8\.A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)
- •At randomization (visit 2\):
Exclusion Criteria
- •At study entry (visit 1\):
- •1\.Previous surgery to the bladder neck, prostate or pelvic region (including thermo\-therapies)
- •2\.Previous pelvic radiation for any cause
- •3\.A post\-voiding residual volume \>250 ml by ultrasound or catheterization in at least two assessments over the last 3 months
- •4\.A known history or diagnosis or any of the following urinary conditions:
- •a)Neurological bladder disorder (including disorders due to diabetic neuropathy)
- •b)Bladder neck stenosis
- •c)Stone in bladder or urethra
- •d)Recurrent urinary tract infection (defined as at least two UTIs within the last 6 months)
- •e)Bladder cancer (including polyposis)
Outcomes
Primary Outcomes
Not specified
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