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NCT02244333 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

Official title:
ALNA® - AWB in Pre-treated Patients With BPS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244333
Other study ID # 527.56
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date February 2004

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 4575
Est. completion date
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• ALNA®

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire Baseline, after 1 month No
Primary Change of Quality of Life (QoL) Index by means on patient questionnaire Baseline, after 1 month No
Primary Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale after 1 month No
Secondary Change from Baseline in maximum urinary flow rate (Qmax) Baseline, after 1 month No
Secondary Change from Baseline in residual urinary volume Baseline, after 1 month No
Secondary Change from Baseline in blood pressure Baseline, after 1 month No
Secondary Change from Baseline in Pulse rate (bpm) Baseline, after 1 month No
Secondary Change in complications due to low blood pressure Patient is asked for complications (weakness, dizziness, nausea) Baseline, after 1 month No
Secondary Global assessment of efficacy by investigator on 4-point scale after 1 month No
Secondary Global assessment of tolerability by investigator on 4-point scale after 1 month No
Secondary Global assessment with BPS- treatment by investigator on a 4-point scale Switch from Terazosin therapy to ALNA® Baseline, after 1 month No
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