Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)

ALNA® - AWB in Pre-treated Patients With BPS

Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: ALNA®

• Study Type: Observational
• Enrollment (Actual): 4575

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists

Description

Inclusion Criteria:

• Suffering from BPS symptoms
• Preceding treating with Terazosin for at least one month
• IPSS sum score >= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin
• Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month

Exclusion Criteria:

• Patients fulfilling one of the general or specific contraindications listed in the ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with symptomatic BPS	Drug: ALNA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire	Baseline, after 1 month
Change of Quality of Life (QoL) Index by means on patient questionnaire	Baseline, after 1 month
Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale	after 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in maximum urinary flow rate (Qmax)		Baseline, after 1 month
Change from Baseline in residual urinary volume		Baseline, after 1 month
Change from Baseline in blood pressure		Baseline, after 1 month
Change from Baseline in Pulse rate (bpm)		Baseline, after 1 month
Change in complications due to low blood pressure	Patient is asked for complications (weakness, dizziness, nausea)	Baseline, after 1 month
Global assessment of efficacy by investigator on 4-point scale		after 1 month
Global assessment of tolerability by investigator on 4-point scale		after 1 month
Global assessment with BPS- treatment by investigator on a 4-point scale	Switch from Terazosin therapy to ALNA®	Baseline, after 1 month

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): July 1, 2004

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 527.56