Once Daily Given Alfuzosin in the Treatment of BPH
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ClinicalTrials.gov Identifier: NCT00637715 |
Recruitment Status :
Completed
First Posted : March 18, 2008
Last Update Posted : April 3, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Benign Prostatic Hyperplasia | Drug: Alfuzosin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms |
Study Start Date : | October 2003 |
Actual Study Completion Date : | December 2004 |

- To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH) [ Time Frame: 6 months ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present
Exclusion Criteria:
- Necessity of surgical intervention immediately or within 12 months because of BPH
- The patient has earlier /within 6 months/ obtained treatment because of BPH
- The patient did not improve on earlier alpha-1 blocker treatment
- Known hypersensitivity to alfuzosin
- Orthostatic hypotension in the history
- Concomitant application with another alpha-1 blocker
- Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
- Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
- Intestinal obstruction /because of the castor oil content of the drug/
- Tumorous disease
- Severe, life threatening state
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637715
Hungary | |
Sanofi-Aventis | |
Budapest, Hungary |
Study Director: | Laszlo Eros | Sanofi |
Responsible Party: | Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00637715 |
Other Study ID Numbers: |
L_8758 |
First Posted: | March 18, 2008 Key Record Dates |
Last Update Posted: | April 3, 2008 |
Last Verified: | April 2008 |
Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases Alfuzosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |