Trial Outcomes & Findings for A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function (NCT NCT00478881)
NCT ID: NCT00478881
Last Updated: 2014-12-11
Results Overview
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).
COMPLETED
PHASE2
397 participants
baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
2014-12-11
Participant Flow
Enrollment started on 31 August 2007 and the last study visit occurred on 13 November 2008. The study was conducted at 56 centers in 13 countries: 45 centers in Europe, 4 centers in Canada, 4 centers in Russia, and 3 centers in Israel.
Number of participants screened: 635. Number of participants enrolled and randomized (started Overall study): 397. Number of participants who had taken at least one dose (Safety population): 396.
Participant milestones
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
198
|
|
Overall Study
Received Medication
|
198
|
198
|
|
Overall Study
COMPLETED
|
160
|
176
|
|
Overall Study
NOT COMPLETED
|
39
|
22
|
Reasons for withdrawal
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
31
|
12
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Non-Compliance with Study Medication
|
0
|
2
|
Baseline Characteristics
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
Baseline characteristics by cohort
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=198 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=198 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)Population: Modified intention-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study.
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).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=122 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=136 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks
|
44.993 mL
Standard Error 9.2774
|
36.948 mL
Standard Error 8.7786
|
PRIMARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed".
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).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=163 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=178 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Average Number of Daily Micturitions at 6 Weeks
|
-2.247 micturitions per day
Standard Error 0.2530
|
-1.579 micturitions per day
Standard Error 0.2431
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Modified intent-to-treat (mITT) population: participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study.
Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=119 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=135 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks
|
0.085 millimeters of mercury (mmHg)
Standard Error 2.5821
|
0.743 millimeters of mercury (mmHg)
Standard Error 2.4199
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study.
First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=121 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=134 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Volume at First Detectable Leakage at 6 Weeks
|
42.307 mL
Standard Error 7.9013
|
26.717 mL
Standard Error 7.5039
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study.
Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=125 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=136 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks
|
40.274 mL
Standard Error 7.4986
|
27.900 mL
Standard Error 7.1839
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study.
Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=125 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=136 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Volume at First Desire to Void at 6 Weeks
|
30.655 mL
Standard Error 6.0503
|
22.460 mL
Standard Error 5.7959
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed".
The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=163 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=178 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks
|
-1.861 urgencies per day
Standard Error 0.2768
|
-1.139 urgencies per day
Standard Error 0.2658
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed".
The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=162 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=178 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks
|
-0.566 involuntary discharges per day
Standard Error 0.1241
|
0.447 involuntary discharges per day
Standard Error 0.1188
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: mITT: Participants who received at least one dose, randomized correctly according to Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. Qmax is based on men predominantly aged 50 years and older but includes a few males who had Qmax collected even if younger than 50 years.
Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=39 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=55 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older
|
1.129 milliliter per second (mL/s)
Standard Error 0.6301
|
0.306 milliliter per second (mL/s)
Standard Error 0.5351
|
SECONDARY outcome
Timeframe: baseline and up to 6 weeks of treatment LOCFPopulation: Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed".
The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF.
Outcome measures
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=156 Participants
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=169 Participants
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks
|
8.929 scores on a scale
Standard Error 1.2627
|
7.834 scores on a scale
Standard Error 1.2181
|
Adverse Events
Vardenafil HCl (Levitra, BAY38-9456)
Placebo
Serious adverse events
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=198 participants at risk
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=198 participants at risk
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/198
|
0.51%
1/198
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/198
|
0.51%
1/198
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/198
|
0.51%
1/198
|
|
Eye disorders
Vision blurred
|
0.51%
1/198
|
0.00%
0/198
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
1/198
|
0.00%
0/198
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/198
|
0.51%
1/198
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.51%
1/198
|
0.00%
0/198
|
|
Nervous system disorders
Headache
|
0.51%
1/198
|
0.00%
0/198
|
|
Nervous system disorders
Multiple sclerosis
|
0.51%
1/198
|
0.00%
0/198
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/198
|
0.51%
1/198
|
|
Vascular disorders
Hypertension
|
0.00%
0/198
|
0.51%
1/198
|
Other adverse events
| Measure |
Vardenafil HCl (Levitra, BAY38-9456)
n=198 participants at risk
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
Placebo
n=198 participants at risk
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
10/198
|
0.51%
1/198
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
4/198
|
0.00%
0/198
|
|
Gastrointestinal disorders
Nausea
|
2.5%
5/198
|
2.0%
4/198
|
|
General disorders
Asthenia
|
2.0%
4/198
|
0.00%
0/198
|
|
General disorders
Fatigue
|
3.5%
7/198
|
1.5%
3/198
|
|
Infections and infestations
Urinary tract infection
|
4.0%
8/198
|
2.5%
5/198
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
8/198
|
2.5%
5/198
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
4/198
|
0.51%
1/198
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
9/198
|
0.51%
1/198
|
|
Nervous system disorders
Dizziness
|
4.0%
8/198
|
2.0%
4/198
|
|
Nervous system disorders
Headache
|
18.7%
37/198
|
9.1%
18/198
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
4/198
|
0.00%
0/198
|
|
Gastrointestinal disorders
Constipation
|
2.0%
4/198
|
0.00%
0/198
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
6/198
|
3.5%
7/198
|
|
Vascular disorders
Flushing
|
2.5%
5/198
|
0.51%
1/198
|
|
Vascular disorders
Hot flush
|
1.0%
2/198
|
2.0%
4/198
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publishing incl confidential information only after Bayer written approval. Manuscript to Bayer 60 days before submission. Confidential Information to be deleted. Other Bayer comments to be considered, if they do not alter the scientific character. If no Bayer comment within 45 days, consider approval given. If multisite study Principal Investigator (PI) not to independently publish results before publication of multisite paper, but PI not restricted from 24 months from study completion onwards.
- Publication restrictions are in place
Restriction type: OTHER