Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

NCT ID: NCT00444925

Last Updated: 2015-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-07-31

Brief Summary

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To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fesoterodine

Tablets

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks

Placebo

Tablets and capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

once daily (OD)for 12 weeks

Tolterodine

Capsules

Group Type ACTIVE_COMPARATOR

tolterodine tartrate

Intervention Type DRUG

4 mg once daily (OD) for 12 weeks

Interventions

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fesoterodine fumarate

4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks

Intervention Type DRUG

placebo

once daily (OD)for 12 weeks

Intervention Type DRUG

tolterodine tartrate

4 mg once daily (OD) for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency \>= 8 per day and urgency urinary incontinence \>=1 per day

Exclusion Criteria

* Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Homewood, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Carmichael, California, United States

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Orangevale, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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Waterbury, Connecticut, United States

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Miami, Florida, United States

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Wellington, Florida, United States

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Atlanta, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Sandpoint, Idaho, United States

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Aurora, Illinois, United States

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West Des Moines, Iowa, United States

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Newton, Kansas, United States

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Shrevport, Louisiana, United States

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Watertown, Massachusetts, United States

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Chaska, Minnesota, United States

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Lawrenceville, New Jersey, United States

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Albuquerque, New Mexico, United States

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Garden City, New York, United States

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Mineola, New York, United States

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Burlington, North Carolina, United States

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Concord, North Carolina, United States

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Huntersville, North Carolina, United States

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Dayton, Ohio, United States

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Allentown, Pennsylvania, United States

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Allentown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Kingsport, Tennessee, United States

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Milan, Tennessee, United States

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Houston, Texas, United States

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Provo, Utah, United States

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Chesapeake, Virginia, United States

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Seattle, Washington, United States

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Menomonee Falls, Wisconsin, United States

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Antwerp, , Belgium

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Brussels, , Belgium

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Kortrijk, , Belgium

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Tessenderlo, , Belgium

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Salvador, Estado de Bahia, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Victoria, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile

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Port Montt, , Chile

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Santiago, , Chile

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Bogota, Cundinamarca, Colombia

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Bogota, Cundinamarca, Colombia

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Alajuela, Alajuela Province, Costa Rica

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Cartago, Cartago Province, Costa Rica

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San José, Provincia de San José, Costa Rica

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Hradec Králové, , Czechia

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Jablonec nad Nisou, , Czechia

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Jindřichův Hradec, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Aarhus N, , Denmark

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Glostrup Municipality, , Denmark

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Herlev, , Denmark

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Kolding, , Denmark

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Nykoebing Falster, , Denmark

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Roskilde, , Denmark

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Ahaus, , Germany

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Alzey, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Karlsruhe, , Germany

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Krumbach, , Germany

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Leipzig, , Germany

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Leipzig, , Germany

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Marburg, , Germany

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Muelheim A.d. Ruhr, , Germany

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München, , Germany

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München, , Germany

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Rosenheim, , Germany

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Athens, Attica, Greece

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Ioannina, Ipiros, Greece

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Rio, Patras, , Greece

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Thessaloniki, , Greece

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Hong Kong, , Hong Kong

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Shatin, , Hong Kong

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Debrecen, , Hungary

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Nyíregyháza, , Hungary

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Szeged, , Hungary

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Szentes, , Hungary

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Hyderabad, Andhra Pradesh, India

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Jaipur, Rajasthan, India

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Vellore, Tamil Nadu, India

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Lucknow, Uttar Pradesh, India

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Latina, , Italy

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Padua, , Italy

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Siena, , Italy

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Batu Caves, Selangor, Malaysia

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Kuala Lumpur, , Malaysia

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Bergen, , Norway

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Hamar, , Norway

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Lysaker, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Sandnes, , Norway

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Lima, Lima Province, Peru

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Surco, Lima region, Peru

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Lodz, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Arad, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Sibiu, , Romania

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Timișoara, , Romania

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Moscow, Russia, Russia

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Saint Petersburg, Russia, Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Rostov-on-Don, , Russia

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Singapore, Singapore, Singapore

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Singapore, Singapore, Singapore

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Bloemfontein, Free State, South Africa

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Parktown, Gauteng, South Africa

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Vosloorus, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Pietermaritzburg, KwaZulu-Natal, South Africa

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Cape Town, , South Africa

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Pretoria, , South Africa

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Seoul, Korea, South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Getafe, Madrid, Spain

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Madrid, Madrid, Spain

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Valencia, Valencia, Spain

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Bilbao, Vizcaya, Spain

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Huskvarna, , Sweden

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Luleå, , Sweden

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Malmo, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Frauenfeld, , Switzerland

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Lucerne, , Switzerland

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Niao-Sung Hsiang, Kaohsiung, Taiwan

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Hualien City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Chernivtsi, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Zaporizhzhia, , Ukraine

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Countries

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United States Belgium Brazil Canada Chile Colombia Costa Rica Czechia Denmark Germany Greece Hong Kong Hungary India Italy Malaysia Norway Peru Poland Romania Russia Singapore South Africa South Korea Spain Sweden Switzerland Taiwan Ukraine

References

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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

Reference Type DERIVED
PMID: 35881009 (View on PubMed)

Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.

Reference Type DERIVED
PMID: 21428726 (View on PubMed)

Related Links

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Other Identifiers

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A0221008

Identifier Type: -

Identifier Source: org_study_id

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