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CompletedNCT02244333Updated Sep 19, 2014

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

An observational study in Prostatic Hyperplasia, sponsored by Boehringer Ingelheim. Completed. Open to male participants. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,575
Sex
Male
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Study summary

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

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Conditions studied

  • Prostatic Hyperplasia

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03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 4,575 is above the median of 215 across 169 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,575 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with symptomatic BPS

    Drug: ALNA®

Interventions

06

What researchers measure

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

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

    Time frame: Baseline, after 1 month

  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

    Switch from Terazosin therapy to ALNA®

    Time frame: Baseline, after 1 month

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02244333
Responsible party
Sponsor
First posted
Sep 19, 2014
Start date
Feb 2004
Primary completion
Jul 2004
Last update
Sep 19, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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