Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Criteria
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