Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

NCT ID: NCT02244320

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Brief Summary

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The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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functional BPH

patients with functional BPH who switched from phytotherapy to ALNA®

Tamsulosin

Intervention Type DRUG

Interventions

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Tamsulosin

Intervention Type DRUG

Other Intervention Names

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ALNA®

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from BPH symptoms
* Preceding treatment with a phytotherapeutic for at least 4 weeks
* IPSS sum score ≥ 8 points prior to treatment start with ALNA®
* Indication for a switch to treatment with ALNA® for a minimum period of 2 months

Exclusion Criteria

* Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
* Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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527.38

Identifier Type: -

Identifier Source: org_study_id

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