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

NCT02244229 | Completed Phase 4

• 1 other identifier: 527.15
• Study Type: interventional
• Target: 403
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire

  Baseline, after 26 weeks of treatment

Secondary Outcomes (6)

• Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire

  up to 52 weeks

• Change in International Prostatic Symptom Score (IPSS)

  up to 52 weeks

• Change in Qmax by means of free flow uroflowmetry

  up to 52 weeks

• Number of patients who withdrew due to inefficacy

  up to 52 weeks

• Number of patients with adverse events

  up to 54 weeks

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Drug: Tamsulosin; Drug: Placebo

Finasteride

ACTIVE COMPARATOR

Drug: Finasteride; Drug: Placebo

Interventions

Tamsulosin DRUG

Tamsulosin

Finasteride DRUG

Finasteride

Placebo DRUG

Finasteride; Tamsulosin

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: April 1, 1998
• Primary Completion: November 1, 2000
• Last Updated: September 19, 2014

Record last verified: 2014-09