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Tamsulosin

Phase 2

Prostatic Hyperplasia | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Dec 19, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment609

FDA Designations

No designations recorded

Clinical trial landscape

Tamsulosin · 1 trial · 1 indication

Phase 2 1
NCT00457457Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.Prostatic Hyperplasia
COMPLETED609 Analytics
PHASE2COMPLETED
Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
Prostatic HyperplasiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in international prostate symptom score
12 weeks

Secondary Endpoints

Erectile Function (EF) domain of International Index of Erectile
12 weeks
Function (IIEF)
12 weeks
Qmax
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ComparatorACTIVE_COMPARATORTamsulosin 0.4 mg prolonged release
Treatment ArmEXPERIMENTALThere are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg),

Interventions

NameTypeDescription
TamsulosinDRUGTamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
UK-369,003DRUGUK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (\>80 fold) compared to sildenafil (\~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED
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Eligibility Criteria

Age Range40 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: 1. Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 2. Clinical diagnosis of BPH. 3. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening). Exclusion Criteria: 1. Urinary tract infection 2. P...

Countries:AustraliaBelgiumCanadaChileColombiaDenmarkFinlandGreeceItalyLatviaLithuaniaPolandSlovakiaSpainUnited Kingdom
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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials (matched to "Prostatic Hyperplasia")

Frequently asked questions about Tamsulosin

What is Tamsulosin used for in Prostatic Hyperplasia?

Tamsulosin is an investigational small molecule being studied for the treatment of Prostatic Hyperplasia, a condition also known as benign prostatic hyperplasia. It is being developed by Pfizer, Inc. and is currently in Phase 2 clinical development for this indication.

Who makes Tamsulosin?

Tamsulosin is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the drug's effects in patients with Prostatic Hyperplasia.

What phase is Tamsulosin in?

Tamsulosin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its potential use in treating Prostatic Hyperplasia, and its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is Tamsulosin in?

Tamsulosin has been studied in one completed Phase 2 clinical trial, identified as NCT00457457. This trial, titled "Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms," enrolled 609 male participants aged 40 years and older with Prostatic Hyperplasia.

Is Tamsulosin the same as UK-369,003?

Yes, Tamsulosin is also known as UK-369,003. The Phase 2 clinical trial NCT00457457 used the name UK-369,003 in its title, confirming that both names refer to the same investigational drug being developed by Pfizer, Inc. for Prostatic Hyperplasia.

How does Tamsulosin work?

Tamsulosin is a small molecule being studied for Prostatic Hyperplasia. The specific molecular target of the drug has not been disclosed in available clinical trial information, so its mechanism of action is not detailed here. The drug is being evaluated for its effects on lower urinary tract symptoms in men.