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

NCT02244333 | Completed

• 1 other identifier: 527.56
• Study Type: observational
• Target: 4,575
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

• Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire

  Baseline, after 1 month

• Change of Quality of Life (QoL) Index 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

Secondary Outcomes (8)

• 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 from Baseline in blood pressure

  Baseline, after 1 month

• Change from Baseline in Pulse rate (bpm)

  Baseline, after 1 month

• Change in complications due to low blood pressure

  Baseline, after 1 month

Study Arms (1)

Patients with symptomatic BPS

Drug: ALNA®

Interventions

ALNA® DRUG

Patients with symptomatic BPS

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: February 1, 2004
• Primary Completion: July 1, 2004
• Last Updated: September 19, 2014

Record last verified: 2014-09