Status:
COMPLETED
Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
Brief Summary
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4575 Patients enrolled
Trial Details
Trial ID
NCT02244333
Start Date
February 1 2004
Last Update
September 19 2014
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