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

Boehringer Ingelheim

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: ALNA®

Study type: Observational

Funder types: Industry

Identifiers

NCT02244333

527.56

Details and patient eligibility

About

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

Enrollment: 4,575 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

4,575 participants in 1 patient group

Patients with symptomatic BPS

Treatment:

Drug: ALNA®