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Last Updated: July 10, 2025

CLINICAL TRIALS PROFILE FOR TOLTERODINE TARTRATE


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All Clinical Trials for Tolterodine Tartrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00143377 ↗ Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB Completed Pfizer Phase 4 2004-09-01 The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.
NCT00143377 ↗ Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 4 2004-09-01 The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.
NCT00293839 ↗ Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder Completed Alza Corporation, DE, USA Phase 3 1969-12-31 The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
NCT00444925 ↗ Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB) Completed Pfizer Phase 3 2007-04-01 To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
NCT00454740 ↗ Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder Completed Astellas Pharma Inc Phase 3 2004-06-01 To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tolterodine Tartrate

Condition Name

Condition Name for Tolterodine Tartrate
Intervention Trials
Overactive Bladder 7
Urinary Bladder, Overactive 3
Urinary Incontinence 2
Atrial Fibrillation 1
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Condition MeSH

Condition MeSH for Tolterodine Tartrate
Intervention Trials
Urinary Bladder, Overactive 12
Urinary Incontinence 4
Enuresis 3
Urinary Incontinence, Urge 2
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Clinical Trial Locations for Tolterodine Tartrate

Trials by Country

Trials by Country for Tolterodine Tartrate
Location Trials
United States 64
India 5
Canada 5
South Africa 5
Brazil 5
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Trials by US State

Trials by US State for Tolterodine Tartrate
Location Trials
California 4
Georgia 3
Florida 3
Texas 3
Connecticut 2
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Clinical Trial Progress for Tolterodine Tartrate

Clinical Trial Phase

Clinical Trial Phase for Tolterodine Tartrate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Tolterodine Tartrate
Clinical Trial Phase Trials
Completed 15
Unknown status 1
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Clinical Trial Sponsors for Tolterodine Tartrate

Sponsor Name

Sponsor Name for Tolterodine Tartrate
Sponsor Trials
Pfizer 6
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 3
APOGEPHA Arzneimittel GmbH 1
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Sponsor Type

Sponsor Type for Tolterodine Tartrate
Sponsor Trials
Industry 16
Other 8
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Tolterodine Tartrate: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Tolterodine Tartrate

Tolterodine tartrate is an antimuscarinic agent widely used to treat symptoms of overactive bladder (OAB), including urinary frequency, urgency, and incontinence. This drug has been a cornerstone in the management of OAB, and its market has seen significant growth driven by various factors.

Clinical Trials: The REMOTE Trial

One of the landmark clinical trials involving tolterodine tartrate is the REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) trial. This trial was the first entirely web-based clinical trial conducted under an Investigational New Drug (IND) application[1][4].

Methodology

The REMOTE trial was designed to evaluate the efficacy and safety of tolterodine extended release (ER) 4 mg for OAB. Participants were recruited via the web, screened using web-based questionnaires, and underwent laboratory testing in their community. Informed consent was obtained through an interactive web-based method with physician countersignature. The study medication was shipped directly to participants[1].

Results

Despite a goal of 283 randomized participants, the trial saw 5157 registrations. After various screening phases, only 18 participants were randomized to treatment. At week 12, the mean change from baseline in micturitions per 24 hours was -2.4 for tolterodine ER versus -0.8 for placebo, indicating efficacy consistent with conventional trials[1].

Implications

The REMOTE trial demonstrated the feasibility and efficacy of web-based clinical trials, offering a participant-friendly approach that could streamline future clinical research[1].

Market Analysis

Current Market Size and Growth

The tolterodine tartrate market has experienced substantial growth, valued at approximately $2.77 billion in 2023. This growth is projected to continue, with the market expected to reach $2.82 billion by the end of the forecast period (2024-2032)[2].

Key Drivers

Several factors are driving the growth of the tolterodine tartrate market:

Rising Prevalence of OAB

The global increase in OAB incidence, attributed to aging populations, rising obesity rates, and increasing cases of diabetes, is a major driver[2].

Advancements in Drug Formulations

Pharmaceutical companies are developing improved formulations, such as extended-release versions, which enhance patient compliance and efficacy[2].

Awareness and Diagnosis

Greater awareness and better diagnostic facilities have led to an increase in the diagnosis and treatment of OAB, contributing to market growth[2].

Investment in Research and Development

Continuous investment in R&D has introduced new and effective drugs for OAB management, positively impacting the tolterodine tartrate market[2].

Market Segmentation

The market is segmented based on product type (pill, capsule), application (urinary incontinence, frequent urination), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[5].

Regional Outlook

Major global regions, including North America, Europe, and Asia-Pacific, are expected to play significant roles in the market's development. The presence of large players and the adoption of advanced technologies in these regions are likely to create ample growth opportunities[2].

Market Projections

Forecast Period

The tolterodine tartrate market is anticipated to experience sustained and significant expansion from 2023 to 2031. The market size is projected to grow substantially, driven by positive market dynamics and expected prolonged expansion[5].

Revenue and Growth Rates

The market is expected to exhibit robust growth rates throughout the forecast period. The detailed compilation of information in market reports provides a thorough overview of the market's development in terms of revenue[5].

Competitive Analysis

The market is competitive, with several key players focusing on new product launches, mergers and acquisitions, and joint ventures. These strategies aim to generate additional revenue streams and maintain market share[2].

Consumer Behavior and Market Dynamics

Consumer Behavior Analysis

Consumer behavior analysis is crucial for understanding the tolterodine tartrate market. Factors such as product pricing, penetration at national and regional levels, and consumer preferences influence market trends[5].

Market Opportunities and Challenges

The market is subject to various opportunities and challenges. Technological innovations and advancements in drug formulations present opportunities, while intense competition and economic impacts pose challenges[2].

Key Players and Strategies

Leading Players

Major players in the tolterodine tartrate market are investing heavily in R&D and adopting various growth strategies, including new product launches and strategic partnerships. These players are also focusing on enhancing their financial matrices through sales and operating income improvements[2].

SWOT Analysis

A SWOT analysis of key players reveals their strengths, weaknesses, opportunities, and threats. This analysis helps in understanding the competitive landscape and the strategies employed by major players to maintain their market position[2].

Conclusion

Tolterodine tartrate remains a vital drug in the management of overactive bladder, with a market that is experiencing significant growth. The success of web-based clinical trials like the REMOTE trial highlights the potential for innovative approaches in clinical research. As the market continues to grow, driven by increasing prevalence of OAB, advancements in drug formulations, and greater awareness and diagnosis, it is clear that tolterodine tartrate will remain a key player in the pharmaceutical industry.

Key Takeaways

  • Web-Based Clinical Trials: The REMOTE trial demonstrated the feasibility and efficacy of web-based clinical trials for tolterodine tartrate.
  • Market Growth: The tolterodine tartrate market is valued at $2.77 billion in 2023 and is projected to grow to $2.82 billion by 2032.
  • Key Drivers: Rising OAB prevalence, advancements in drug formulations, greater awareness and diagnosis, and R&D investments are driving market growth.
  • Market Segmentation: The market is segmented by product type, application, and geographical regions.
  • Competitive Landscape: Major players are focusing on R&D, new product launches, and strategic partnerships to maintain market share.

FAQs

What is the primary use of tolterodine tartrate?

Tolterodine tartrate is primarily used to treat symptoms of overactive bladder (OAB), including urinary frequency, urgency, and incontinence.

What was the REMOTE trial, and what were its findings?

The REMOTE trial was the first entirely web-based clinical trial conducted under an IND application to evaluate the efficacy and safety of tolterodine ER 4 mg for OAB. The trial found that the efficacy observed was consistent with results from conventional trials.

What are the key drivers of the tolterodine tartrate market growth?

The key drivers include the rising prevalence of OAB, advancements in drug formulations, greater awareness and diagnosis, and continuous investment in R&D.

How is the tolterodine tartrate market segmented?

The market is segmented based on product type (pill, capsule), application (urinary incontinence, frequent urination), and geographical regions.

What is the projected market size of tolterodine tartrate by 2032?

The market is projected to reach $2.82 billion by 2032, driven by positive market dynamics and expected prolonged expansion.

Sources

  1. PubMed: "Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg for overactive bladder: the REMOTE trial."
  2. OpenPR: "Tolterodine Tartrate Market In-depth Analysis - openPR.com"
  3. AUAJournals: "Prediction of Medicare Drug Formulary Drugs for Treatment of Overactive Bladder Syndrome"
  4. Pfizer: "Pfizer Conducts First “Virtual” Clinical Trial Allowing Patients to Participate Regardless of Geography"
  5. Market Research Intellect: "Tolterodine Tartrate Market Size, Scope And Forecast Report"

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