Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

Phase 4

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Finasteride; Drug: Tamsulosin; Drug: Placebo

• Registration Number: NCT02244229
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 2000-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 403

Inclusion Criteria

• Male out-patients aged 50-80 years
• IPSS >= 13 at Visit 1
• Qmax: 4-15 ml/sec at Visit 2
• Residue urinary volume > 400 ml as evaluated by ultrasonography
• SPI >= 7 at Visit 2
• Prostate Specific Antigen (PSA) value < 3 ng/ml at Visit 1, or of 3-10 ng/ml provided that prostate cancer is ruled out on the basis of the usual diagnostic procedures performed at each Centre
• Written informed consent

Exclusion Criteria

Patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study:

• Urological disturbances

  • Medical history of pelvic surgery; palpable bladder at the physical examination, or residue urinary volume > 400 ml; known neurological bladder disorder, bladder neck stenosis, urethral stricture, bladder or prostatic cancer, bladder stone, severe diverticulum of the bladder, symptomatic urinary tract infection during the last month, or recurrent urinary tract infections (more than 2 during the last year); hematuria of unknown origin; diseases that may affect micturition (e.g. diabetes mellitus)

• Cardiovascular diseases - The following cardiovascular diseases if occurred in the last 6 months:

  • Myocardial infarction
  • Unstable angina
  • Clinically significant ventricular arrhythmias
  • Heart failure (NYHA classes III/IV)
  • Orthostatic hypotension
  • Cerebral stroke

• Neurological diseases

  • such as senile dementia, multiple sclerosis, Parkinson's disease, psychiatric disturbances, if their severity could have prevented the correct performance of the trial

• Hepatic or renal insufficiency

  • (Biochemistry values 15% outside normal laboratory ranges and regarded as clinically relevant by investigator)

• Clinically significant abnormalities in the results of hematologic and biochemical tests performed on blood samples drawn at the screening visit

• Patients who are taking or have been taking α-blockers for BPH or for hypertension or phytotherapy for BPH in the previous 6 weeks

• Patients who are taking or have been taking finasteride in the last 6 months

• Patients who require concomitant drugs which could influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. In particular: alpha-blockers and mixed alpha-beta blockers, alpha- agonists, anti-cholinergics

• Patient who are or have been taking part in a clinical study in the previous 3 months

• Patients who have hypersensitivity or allergic reactions to previously prescribed alpha-blocker(s) or to finasteride

• Patients judged by the investigator to be inappropriate for inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finasteride	Finasteride	-
Finasteride	Placebo	-
Tamsulosin	Placebo	-
Tamsulosin	Tamsulosin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire	Baseline, after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change in International Prostatic Symptom Score (IPSS)	up to 52 weeks	questionnaire for the self-evaluation of urinary symptoms
Number of patients with adverse events	up to 54 weeks
Number of patients who withdrew due to inefficacy	up to 52 weeks
Change in Qmax by means of free flow uroflowmetry	up to 52 weeks
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire	up to 52 weeks
Number of patients with abnormal changes in laboratory parameters	up to 52 weeks