The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Boehringer Ingelheim

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: ALNA®OCAS®

Study type: Observational

Funder types: Industry

Identifiers

NCT02245542

527.68

Details and patient eligibility

About

Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia

Enrollment: 5,775 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months

Exclusion criteria

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

Trial design

5,775 participants in 1 patient group

BPH patients

Treatment:

Drug: ALNA®OCAS®