Prostatic HyperplasiaNCT02244333
Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- ALNA®
- How many people
- 4,575 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Jul 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: ALNA® - AWB in Pre-treated Patients With BPS
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
- Conditions
- Prostatic Hyperplasia
- Being tested
- ALNA®
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALNA®Drug
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic BPS | Not described Receives: Drug: ALNA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire
Measured: Baseline, after 1 month
Change of Quality of Life (QoL) Index by means on patient questionnaire
Measured: Baseline, after 1 month
Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale
Measured: after 1 month
Secondary outcomes (8)
Change from Baseline in maximum urinary flow rate (Qmax)
Measured: Baseline, after 1 month
Change from Baseline in residual urinary volume
Measured: Baseline, after 1 month
Change from Baseline in blood pressure
Measured: Baseline, after 1 month
Change from Baseline in Pulse rate (bpm)
Measured: Baseline, after 1 month
Change in complications due to low blood pressure
Patient is asked for complications (weakness, dizziness, nausea)
Measured: Baseline, after 1 month
Global assessment of efficacy by investigator on 4-point scale
Measured: after 1 month
Global assessment of tolerability by investigator on 4-point scale
Measured: after 1 month
Global assessment with BPS- treatment by investigator on a 4-point scale
Switch from Terazosin therapy to ALNA®
Measured: Baseline, after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startFeb 2004
- Primary completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244333
- Sponsor's protocol ID
- 527.56
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALNA® - AWB in Pre-treated Patients With BPS
- ClinicalTrials.gov ID
- NCT02244333
- Acronym / sponsor ID
- 527.56
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,575 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jul 2004 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic BPS | – | Drug: ALNA® |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALNA® | Drug | Patients with symptomatic BPS |
Primary outcome
Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire
Time frame: Baseline, after 1 month
Change of Quality of Life (QoL) Index by means on patient questionnaire
Time frame: Baseline, after 1 month
Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale
Time frame: after 1 month
8 secondary outcomes
Change from Baseline in maximum urinary flow rate (Qmax)
Time frame: Baseline, after 1 month
Change from Baseline in residual urinary volume
Time frame: Baseline, after 1 month
Change from Baseline in blood pressure
Time frame: Baseline, after 1 month
Change from Baseline in Pulse rate (bpm)
Time frame: Baseline, after 1 month
Change in complications due to low blood pressure
Time frame: Baseline, after 1 month
Global assessment of efficacy by investigator on 4-point scale
Time frame: after 1 month
Global assessment of tolerability by investigator on 4-point scale
Time frame: after 1 month
Global assessment with BPS- treatment by investigator on a 4-point scale
Time frame: Baseline, after 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire (time frame: Baseline, after 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.