A randomized, double blind, double dummy, placebo controlled, parallel group study to determine the effect of BXL628 in monotherapy (75 mcg and 150 mcg) and in combination (150 mcg) with tamsulosin (0.4 mg) in patients with benign prostatic hyperplasia (BPH)
- Conditions
- Benign Prostatic Hyperplasia (BPH)MedDRA version: 8Classification code 10004446
- Registration Number
- EUCTR2005-000154-76-DE
- Lead Sponsor
- BioXell S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 512
- Males aged at least 50 years
- Diagnosis of BPH according to medical history and physical
examination, including digital rectal examination
- Prostate volume > 30 ml as determined by TRUS (a TRUS
performed within the last 12 months before the start of the
study will be accepted)
- IPSS = 12
- 4 < Qmax < 15 ml/s with a minimum voided volume of 125 ml
- Ability to fully understand all study procedures and to
provide written informed consent to study participation
- Ability to comply with dosing and study visits scheduled for
the duration of 6 months
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
- Patients unable and/or unlikely to comprehend and follow
the study procedures and instructions
- Evidence of hepatic disease (total bilirubin > 1.5 x upper
limit of normal, or AST or ALT or alkaline phosphatase > 2
x upper limit of normal)
- Evidence of renal insufficiency (creatinine > 1.5 x upper
limit of normal)
- Patients who are taking or have taken prohibited medications
- History of disturbed calcium, phosphorus or magnesium
metabolism
- Patients with clinically significant bladder outlet obstruction
and/or patients with a post void residual volume (PVR),
measured by pelvic ultrasound, greater than 250 ml
- History of acute urinary retention or history of repeated
catheterizations due to acute urinary retention and BPH
within 3 months prior to visit 1
- Serum PSA values of < 1.5 ng/ml
- Supine blood pressure < 90/70 mmHg
- Orthostatic hypotension history
- An episode of unstable angina pectoris, a myocardial
infarction, transient ischemic attack or a cerebrovascular
accident within the past 6 months prior to visit 1
- Patients who have undergone prostatic surgery or bladder
biopsy or any other minor pelvic surgical intervention less
than 30 days prior to visit 1
- History or current evidence of prostate cancer
- Bladder cancer untreated or treated by partial cystectomy
- Patients with acute or recurrent urinary tract infection (UTI)
and/or unexplained haematuria
- Stone in the bladder or urethra and upper tract stone disease
causing symptoms
- Acute or chronic (documented) prostatitis
- Interstitial cystitis (documented by symptoms and/or biopsy)
- Patients with other clinically significant systemic diseases
- Patients with an indwelling catheter and patients practising
intermittent self-catheterisation
- Patients who have received any investigational drug during
the preceding 30 days prior to visit 1or 5 times the plasma
half life (if known), whichever is longer, or who have
previously participated in this trial
- Patients who are abusers of alcohol and/or other drugs
- Patients who intend to donate blood or blood products
during the study or within one month following the
completion of the study
- Patients with allergy, hypersensitivity or other medical
contraindications to Vitamin D and to alpha-blockers
- Contraindications to the use of MRI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of three different therapeutic regimens in reducing prostatic size.;Secondary Objective: To determine:<br>- the effect of three different therapeutic regimens in reducing the transitional zone<br>volume of the prostate<br>- the effect of three different therapeutic regimens on maximum urinary flow rate<br>(Qmax)<br>- the effect of three different therapeutic regimens on symptoms severity by the<br>International Prostate Symptom Score (IPSS) and<br>by a 24 hour micturition diary<br>- the effect of three different therapeutic regimens on QoL measured by the BPH Impact Index (BII)<br>- the effect of three different therapeutic regimens on sexual function measured by the Brief Sexual Function Inventory (BSFI)<br>- the safety and tolerability of three different therapeutic regimens.;Primary end point(s): The prostatic size centrally evaluated by MRI at baseline and end of the study.
- Secondary Outcome Measures
Name Time Method