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

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: ALNA®

• Registration Number: NCT02244333
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-07
• 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: 4575

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with symptomatic BPS	ALNA®	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in International Prostatic Symptom Score (IPSS) 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
Change of Quality of Life (QoL) Index by means on patient questionnaire	Baseline, after 1 month

Secondary Outcome Measures

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