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SL77.0499-10

Phase 2

Benign Prostatic Hyperplasia | Small molecule | Urology |Sanofi|Last Updated: Oct 2, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment473

FDA Designations

No designations recorded

Clinical trial landscape

SL77.0499-10 · 1 trial · 1 indication

Phase 2 1
NCT00409357Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic HyperplasiaBenign Prostatic Hyperplasia
COMPLETED473 Analytics
PHASE2COMPLETED
Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia
Benign Prostatic HyperplasiaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.

Secondary Endpoints

Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.
Safety: adverse events, vital signs, laboratory tests.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SL77.0499-10 (alfuzosin hydrochloride)DRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * suffering from LUTS related to BPH for at least 6 months; * having an IPSS \>13; * having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL; * having a residual urine volume \< or = 200 mL.

Countries:Japan
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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials

Frequently asked questions about SL77.0499-10

What is SL77.0499-10 used for?

SL77.0499-10 is an investigational small molecule being developed for benign prostatic hyperplasia (BPH), a condition that causes lower urinary tract symptoms. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes SL77.0499-10?

SL77.0499-10 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for benign prostatic hyperplasia.

What phase is SL77.0499-10 in?

SL77.0499-10 is in Phase 2 clinical development. It is an investigational drug for benign prostatic hyperplasia and has not been approved for commercial use. One Phase 2 trial has been completed.

What clinical trials is SL77.0499-10 in?

SL77.0499-10 has one completed clinical trial, NCT00409357, a Phase 2 dose-ranging study in patients with lower urinary tract symptoms related to benign prostatic hyperplasia. The trial enrolled 473 male participants aged 50 years and older in Japan.

Is SL77.0499-10 the same as alfuzosin?

SL77.0499-10 is not the same as alfuzosin. The completed clinical trial NCT00409357 was a dose-ranging study of alfuzosin, not SL77.0499-10. SL77.0499-10 is a separate investigational drug being developed by Sanofi for benign prostatic hyperplasia.