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

NCT ID: NCT02244229

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tamsulosin

Group Type: EXPERIMENTAL

Tamsulosin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Finasteride

Group Type: ACTIVE_COMPARATOR

Finasteride

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Tamsulosin

Intervention Type: DRUG

Finasteride

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

527.15

Identifier Type: -

Identifier Source: org_study_id