CLINICAL TRIALS PROFILE FOR FLOMAX

All Clinical Trials for FLOMAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	GlaxoSmithKline	Phase 3	2005-11-01	The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00209131 ↗	Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy	Terminated	Emory University	N/A	2005-04-01	The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.

Clinical Trial Conditions for FLOMAX

Condition Name

Condition Name for FLOMAX
Intervention	Trials
Benign Prostatic Hyperplasia	6
Prostatic Hyperplasia	6
Urinary Retention	4
Overactive Bladder	3

Condition MeSH

Condition MeSH for FLOMAX
Intervention	Trials
Prostatic Hyperplasia	13
Hyperplasia	13
Urinary Retention	10
Nephrolithiasis	6

Clinical Trial Locations for FLOMAX

Trials by Country

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−

Trials by Country for FLOMAX
Location	Trials
United States	52
Canada	7
Korea, Republic of	7
Australia	3
Germany	3

Trials by US State

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−

Trials by US State for FLOMAX
Location	Trials
California	5
New Jersey	3
Alabama	3
New York	3
Texas	3

Clinical Trial Progress for FLOMAX

Clinical Trial Phase

Clinical Trial Phase for FLOMAX
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for FLOMAX
Clinical Trial Phase	Trials
Completed	28
Terminated	5
Unknown status	5

Clinical Trial Sponsors for FLOMAX

Sponsor Name

Sponsor Name for FLOMAX
Sponsor	Trials
GlaxoSmithKline	6
Boehringer Ingelheim	6
Hackensack Meridian Health	2

Sponsor Type

Sponsor Type for FLOMAX
Sponsor	Trials
Other	35
Industry	21
U.S. Fed	2

Flomax (Tamsulosin): Clinical Trials, Market Analysis, and Projections

Introduction to Flomax (Tamsulosin)

Flomax, known generically as tamsulosin, is an alpha-1 adrenergic receptor antagonist primarily used to relieve the symptoms of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Efficacy and Safety of Tamsulosin

Immediate and Long-Term Efficacy

Clinical trials have consistently shown that tamsulosin provides immediate and sustained relief from BPH/LUTS symptoms. Studies have demonstrated that the effects of tamsulosin are noticeable within the first month of treatment and persist for over 12 months, and in some cases, up to 6 years[1][4].

• Symptom Improvement: Tamsulosin significantly reduces symptoms such as urinary frequency, urgency, weak stream, straining, and nocturia. The International Prostate Symptom Score (I-PSS) and quality of life (QOL) scores show significant improvements that are maintained over long-term treatment[1][4].
• Urodynamic Parameters: Tamsulosin increases the average and maximum urine flow rates (Qave and Qmax) and decreases post-void residual urine volume (PVR), indicating improved urinary flow and reduced bladder outlet obstruction[1][4].

Safety and Tolerability

Tamsulosin is well-tolerated in the long term. Studies have reported low rates of discontinuation due to side effects, with orthostatic hypotension being one of the rare but notable side effects, affecting about 1.3% of patients[4].

• Long-Term Safety: A 6-year study showed that tamsulosin maintained its safety profile, with no significant increase in adverse events over the extended treatment period[4].
• Common Side Effects: While generally well-tolerated, common side effects include dizziness, headache, and ejaculation disorders. However, these are typically mild and do not lead to high discontinuation rates[3].

Market Analysis and Projections

Current Market Size and Growth

The tamsulosin market is substantial and growing. As of 2023, the market size was valued at USD 1.45 billion and is projected to reach USD 3.1 billion by 2030, with a compound annual growth rate (CAGR) of 8.25% during the forecast period of 2024-2030[2].

• Regional Market: The market is segmented globally, with significant shares in North America, Europe, and the Asia Pacific. The hospital segment accounts for a noticeable share of the global tamsulosin market and is expected to experience significant growth[5].

Market Drivers and Trends

Several factors drive the growth of the tamsulosin market:

• Increasing Prevalence of BPH: The rising incidence of BPH due to an aging population is a key driver. As the population ages, the demand for effective treatments like tamsulosin increases[2].
• Economic and Social Factors: Government spending on healthcare, research and development in pharmaceuticals, and changes in social and economic factors also influence market growth[2].
• Competitive Landscape: The market is competitive, with several key players focusing on expanding their product portfolios and business in the global market. Sanofi-Aventis, among others, is expected to retain a significant position throughout the forecast period[5].

Forecast and Projections

The tamsulosin market is expected to continue its growth trajectory due to several factors:

• Forecast Period: From 2025 to 2031, the market is anticipated to grow significantly, driven by increasing demand and advancements in healthcare[5].
• Segment Analysis: The market is segmented by type (e.g., capsules) and application (e.g., hospitals), with each segment expected to contribute to the overall growth. The hospital segment is projected to experience significant growth in the near future[5].

Economic Efficiency and Cost-Effectiveness

Cost-Effectiveness Studies

Studies have evaluated the cost-effectiveness of tamsulosin compared to other treatments for BPH. A report based on clinical trials and economic models indicates that tamsulosin is cost-effective as an initial treatment for moderate BPH over a two-year period from a payer perspective[3].

• Comparison with Other Treatments: Tamsulosin has been compared to other alpha-1 adrenergic blockers like doxazosin and terazosin, showing favorable outcomes in terms of both clinical effectiveness and economic efficiency[3].

Conclusion

Tamsulosin, marketed as Flomax, is a highly effective and well-tolerated medication for the treatment of BPH/LUTS. Clinical trials have consistently demonstrated its immediate and long-term efficacy, as well as its safety profile. The market for tamsulosin is robust and growing, driven by an aging population and increasing healthcare spending.

Key Takeaways

• Clinical Efficacy: Tamsulosin provides immediate and sustained relief from BPH/LUTS symptoms.
• Safety and Tolerability: It is well-tolerated with a low rate of discontinuation due to side effects.
• Market Growth: The tamsulosin market is expected to grow significantly, reaching USD 3.1 billion by 2030.
• Economic Efficiency: Tamsulosin is cost-effective compared to other treatments for BPH.

FAQs

What is the primary use of Flomax (tamsulosin)?

Flomax (tamsulosin) is primarily used to relieve the symptoms of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS).

How quickly does tamsulosin start to work?

Tamsulosin starts to work within the first month of treatment, with significant improvements in symptoms and urodynamic parameters[1].

What are the common side effects of tamsulosin?

Common side effects include dizziness, headache, and ejaculation disorders, although these are typically mild and do not often lead to treatment discontinuation[3].

How is the tamsulosin market projected to grow?

The tamsulosin market is projected to grow from USD 1.45 billion in 2023 to USD 3.1 billion by 2030, with a CAGR of 8.25% during the forecast period[2].

Is tamsulosin cost-effective compared to other BPH treatments?

Yes, tamsulosin has been shown to be cost-effective as an initial treatment for moderate BPH over a two-year period from a payer perspective[3].

What is the long-term safety profile of tamsulosin?

Tamsulosin has been shown to be safe and well-tolerated over long-term use, up to 6 years, with low rates of discontinuation due to side effects[4].

Sources

1. Long-Term Efficacy of Tamsulosin in the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Real-Life Practice. UroToday.
2. Tamsulosin Market Size, Share, Scope, Trends And Forecast 2030. Verified Market Reports.
3. FLOMAX - CiteSeerX.
4. Long-term Safety and Efficacy of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. AUAJournals.
5. Tamsulosin Market Report 2024 (Global Edition). Cognitive Market Research.