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SL77.0499-10

Phase 2

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

SL77.0499-10 target and mechanism

ModalitySmall molecule

Also known as SL77.0499-10 (alfuzosin hydrochloride)

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

SL77.0499-10 clinical trials

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 10 trials

Top 1 of 6 competitors

CompanyTickerTrialsLead PhaseDrugs
Medicus Pharma LtdMDCX1PHASE2Teverelix DP
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Frequently asked questions about SL77.0499-10

What is SL77.0499-10 used for?

SL77.0499-10 is being developed for benign prostatic hyperplasia, a urological condition that causes lower urinary tract symptoms in men. It is a small molecule in Phase 2 development. The clinical program has studied it in men aged 50 years and older with lower urinary tract symptoms related to benign prostatic hyperplasia.

Who is developing SL77.0499-10?

SL77.0499-10 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this small molecule in benign prostatic hyperplasia. The asset is in Phase 2 development in the urology therapeutic area.

What phase is SL77.0499-10 in?

SL77.0499-10 is in Phase 2 development. It is an investigational small molecule and has not been approved for marketing. One Phase 2 trial has been completed, and there are no active trials for this asset.

What clinical trials is SL77.0499-10 in?

SL77.0499-10 has been studied in one completed Phase 2 trial, NCT00409357, titled a dose ranging study of alfuzosin in patients with lower urinary tract symptoms related to benign prostatic hyperplasia. The trial enrolled 473 participants in Japan, was randomized and double blind, and included men aged 50 years and older.

Is SL77.0499-10 the same as alfuzosin hydrochloride?

Yes. SL77.0499-10 is also known as SL77.0499-10 (alfuzosin hydrochloride). The two names refer to the same small molecule asset being developed by Sanofi for benign prostatic hyperplasia.