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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with symptomatic BPS

ALNA®

Intervention Type DRUG

Interventions

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ALNA®

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No