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OpenTrials
Completed

NCT Number: NCT02244333

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

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

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALNA®

Drug

Primary outcomes

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

    Time frame: Baseline, after 1 month

  2. Change of Quality of Life (QoL) Index by means on patient questionnaire

    Time frame: Baseline, after 1 month

  3. Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale

    Time frame: after 1 month

Secondary outcomes

  1. Change from Baseline in maximum urinary flow rate (Qmax)

    Time frame: Baseline, after 1 month

  2. Change from Baseline in residual urinary volume

    Time frame: Baseline, after 1 month

  3. Change from Baseline in blood pressure

    Time frame: Baseline, after 1 month

  4. Change from Baseline in Pulse rate (bpm)

    Time frame: Baseline, after 1 month

  5. Change in complications due to low blood pressure

    Time frame: Baseline, after 1 month

    Patient is asked for complications (weakness, dizziness, nausea)

  6. Global assessment of efficacy by investigator on 4-point scale

    Time frame: after 1 month

  7. Global assessment of tolerability by investigator on 4-point scale

    Time frame: after 1 month

  8. Global assessment with BPS- treatment by investigator on a 4-point scale

    Time frame: Baseline, after 1 month

    Switch from Terazosin therapy to ALNA®

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

ALNA® - AWB in Pre-treated Patients With BPS

Important dates

Study start
2004
Primary completion
2004
First posted
Sep 19, 2014
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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