A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

NCT00478881 | Completed Phase 2 Results

• 2 other identifiers: 123922006-005145-11
• Study Type: interventional
• Target: 397
• Locations: 13 countries
• Sites: 55

Brief Summary

The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

Conditions

Overactive Bladder; Detrusor Overactivity

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks

  Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).

  baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)

• Change From Baseline in Average Number of Daily Micturitions at 6 Weeks

  Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).

  baseline and up to 6 weeks of treatment LOCF

Secondary Outcomes (8)

• Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks

  baseline and up to 6 weeks of treatment LOCF

• Change From Baseline in Volume at First Detectable Leakage at 6 Weeks

  baseline and up to 6 weeks of treatment LOCF

• Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks

  baseline and up to 6 weeks of treatment LOCF

• Change From Baseline in Volume at First Desire to Void at 6 Weeks

  baseline and up to 6 weeks of treatment LOCF

• Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks

  baseline and up to 6 weeks of treatment LOCF

Study Arms (2)

Vardenafil HCl (Levitra, BAY38-9456)

EXPERIMENTAL

vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks

Drug: Vardenafil HCl (Levitra, BAY38-9456)

Placebo

PLACEBO COMPARATOR

vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Drug: Placebo

Interventions

Vardenafil HCl (Levitra, BAY38-9456) DRUG

vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks

Vardenafil HCl (Levitra, BAY38-9456)

Placebo DRUG

vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged \> 18 years (females either postmenopausal or using adequate birth control)
• Urodynamic criteria:
• Entire bladder capacity (= maximum cystometric bladder capacity) \< 300 mL OR
• In accordance with International Continence Society (ICS)-guidelines: Detrusor overactivity as defined as spontaneous involuntary detrusor contraction during filling phase OR
• Detrusor contraction during filling phase leading to involuntarily initiated micturition before a normal bladder capacity is reached
• Patient micturition diary criteria: at least 8 micturitions per day AND at least 1 urgency episode per day
• Signed and dated written Patient Informed Consent Form

You may not qualify if:

• Treatment with drugs known to affect urinary bladder function
• Known other reasons for micturition problems than detrusor overactivity
• Recent intervention in urogenital tract
• Abnormal liver or renal lab values
• Treatment with nitrates or nitric oxide donors, alpha-blockers, potent inhibitors of CYP-450 3A4, acenocoumarol, heparin, drugs known to prolong QT-interval
• NAION, hereditary regenerative retinal disorders, severe cardiovascular conditions, recent history of myocardial infarction/stroke/life-threatening arrhythmia
• congenital QT-prolongation, left ventricular outflow obstruction, severe hypo- or hypertension, symptomatic postural hypotension
• History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
• Significant active peptic ulceration
• Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
• In men: Clinically significant chronic haematological disease which may lead to priapism
• History of malignancy of any organ system within the past 5 years
• Bleeding disorder

Sponsors & Collaborators

• Bayer: lead

Study Sites (55)

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Bruxelles - Brussel, 1200, Belgium

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Victoria, British Columbia, V8V 3N1, Canada

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Brantford, Ontario, N3R 4N3, Canada

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Kitchener, Ontario, N2N 2B9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Olomouc, 775 20, Czechia

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Prague, 140 59, Czechia

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Prague, 160 00, Czechia

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Paris, 75571, France

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Paris, 75970, France

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Emmendingen, Baden-Wurttemberg, 79312, Germany

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Bad Griesbach-Therme, Bavaria, 94086, Germany

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Weiden, Bavaria, 92637, Germany

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Schwedt, Brandenburg, 16303, Germany

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Greifswald, Mecklenburg-Vorpommern, 17475, Germany

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Düsseldorf, North Rhine-Westphalia, 40235, Germany

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Essen, North Rhine-Westphalia, 45147, Germany

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Mönchengladbach, North Rhine-Westphalia, 41063, Germany

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Wuppertal, North Rhine-Westphalia, 42103, Germany

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Neunkirchen, Saarland, 66538, Germany

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Leipzig, Saxony, 04103, Germany

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Berlin, State of Berlin, 10115, Germany

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Berlin, State of Berlin, 13347, Germany

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Budapest, 1082, Hungary

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Budapest, 1126, Hungary

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Haifa, Israel, 31096, Israel

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Jerusalem, Israel, 91031, Israel

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Petah Tikva, Israel, Israel

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Eindhoven, North Brabant, 5623 EJ, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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Rotterdam, 3015 CE, Netherlands

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Utrecht, 3584 CX, Netherlands

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Bydgoszcz, 85-168, Poland

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Chorzów, 41-500, Poland

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Siedlce, 08-110, Poland

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Warsaw, 01-432, Poland

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Warsaw, 02-005, Poland

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Warsaw, 02-777, Poland

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Amadora, 2720-276, Portugal

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Lisbon, 1069-166, Portugal

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Porto, 4050-013, Portugal

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Porto, 4099-001, Portugal

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S. Martinho Do Bispo, 3046-853, Portugal

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Moscow, 105425, Russia

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Moscow, 125206, Russia

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Saint Petersburg, 198013, Russia

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Santiago de Compostela, A Coruña, 15706, Spain

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Barcelona, Barcelona, 08035, Spain

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Barcelona, Barcelona, 08036, Spain

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Granada, Granada, 18014, Spain

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Madrid, Madrid, 28046, Spain

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Valencia, Valencia, 46010, Spain

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Basel, Canton of Basel-City, 4031, Switzerland

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Limitations and Caveats

635 participants were screened; 238 were not randomized because they did not fulfill the inclusion/exclusion criteria. Cystometric bladder compliance not presented since only relevant to characterization of detrusor overactivity, not to efficacy.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 25, 2007
• Study Start: August 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 11, 2014
• Results First Posted: December 24, 2009

Record last verified: 2014-11

Locations

PT (5); PL (6); RU (3); CH (1); BE (1); DE (13); HU (2); IL (3); CZ (3); NL (6); FR (2); ES (6); CA (4)