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Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Udenafil 50 mg | Experimental | 50 mg Udenafil tablet plus 100 & 150 mg placebo tablets |
|
| Udenafil 100 mg | Experimental | 100 mg Udenafil tablet plus 50 & 150 mg placebo tablets |
|
| Udenafil 150mg | Experimental | 150 mg Udenafil tablet plus 50 & 100 mg placebo tablets |
|
| Placebo | Placebo Comparator | 50, 100 & 150 mg placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil | Drug | Tablets via oral administration before an attempt at sexual intercourse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection? | Baseline and Week 12 |
| Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | Baseline and Weeks 1-12 |
| Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | Baseline and Weeks 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| Warner Chilcott Investigational Site |
Not provided
First Subject enrolled 28-Sep-2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Udenafil 50 mg | Udenafil 50 mg tablets |
| FG001 | Udenafil 100 mg | Udenafil 100 mg tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Tablets via oral administration before an attempt at sexual intercourse. |
|
| Baseline and Week 12 |
| Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)? | Baseline and Week 12 |
| Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire? | Baseline and Week 12 |
| Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner? | Baseline and Week 12 |
| Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population | While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders) | Week 12 |
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT | EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness? | Baseline and Week 12 |
| Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population | PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity | Baseline and Week 12 |
| Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT | SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | Baseline and Weeks 1-12 |
| Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT | SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | Baseline and Weeks 1-12 |
| Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT | SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | Baseline and Weeks 1-12 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Warner Chilcott Investigational Site | Tempe | Arizona | 85282 | United States |
| Warner Chilcott Investigational Site | Chino | California | 91710 | United States |
| Warner Chilcott Investigational Site | Tarzana | California | 91356 | United States |
| Warner Chilcott Investigational Site | Englewood | Colorado | 80113 | United States |
| Warner Chilcott Investigational Site | Milford | Connecticut | 06460 | United States |
| Warner Chilcott Investigational Site | Aventura | Florida | 33180 | United States |
| Warner Chilcott Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Warner Chilcott Investigational Site | DeLand | Florida | 32720 | United States |
| Warner Chilcott Investigational Site | Ocala | Florida | 34471 | United States |
| Warner Chilcott Investigational Site | Tampa | Florida | 33607 | United States |
| Warner Chilcott Investigational Site | Dawsonville | Georgia | 30534 | United States |
| Warner Chilcott Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Warner Chilcott Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| Warner Chilcott Investigational Site | Greenwood | Indiana | 46143 | United States |
| Warner Chilcott Investigational Site | West Des Moines | Iowa | 50266 | United States |
| Warner Chilcott Investigational Site | Elkridge | Maryland | 21075 | United States |
| Warner Chilcott Investigational Site | Greenbelt | Maryland | 20770 | United States |
| Warner Chilcott Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Warner Chilcott Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Warner Chilcott Investigational Site | Bay Shore | New York | 11706 | United States |
| Warner Chilcott Investigational Site | Brooklyn | New York | 11219 | United States |
| Warner Chilcott Investigational Site | Kingston | New York | 12401 | United States |
| Warner Chilcott Investigational Site | New York | New York | 10016 | United States |
| Warner Chilcott Investigational Site | Poughkeepsie | New York | 12601 | United States |
| Warner Chilcott Investigational Site | Williamsville | New York | 14221 | United States |
| Warner Chilcott Investigational Site | Cary | North Carolina | 27518 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Warner Chilcott Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Warner Chilcott Investigational Site | Cleveland | Ohio | 44122 | United States |
| Warner Chilcott Investigational Site | Jenkintown | Pennsylvania | 19046 | United States |
| Warner Chilcott Investigational Site | Lancaster | Pennsylvania | 17604-3200 | United States |
| Warner Chilcott Investigational Site | Greer | South Carolina | 29650 | United States |
| Warner Chilcott Investigational Site | Arlington | Texas | 76017 | United States |
| Warner Chilcott Investigational Site | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Investigational Site | Norfolk | Virginia | 23502 | United States |
| Warner Chilcott Investigational Site | Richmond | Virginia | 23294 | United States |
| Warner Chilcott Investigational Site | Mountlake Terrace | Washington | 98043 | United States |
| FG002 |
| Udenafil 150mg |
Udenafil 150mg tablets |
| FG003 | Placebo | Placebo tablets |
| Safety Population |
|
| mITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects Randomized/Enrolled; Age, Ethnic, Race only available for Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Udenafil 50 mg | Udenafil 50 mg tablets |
| BG001 | Udenafil 100 mg | Udenafil 100 mg tablets |
| BG002 | Udenafil 150mg | Udenafil 150mg tablets |
| BG003 | Placebo | Placebo tablets |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Race Safety Population | Number | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Safety Population | Number | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection? | mITT, LOCF | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Yes Reponses | Baseline and Weeks 1-12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Yes Responses | Baseline and Weeks 1-12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse? | mITT, LOCF | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)? | mITT, LOCF | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
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| Secondary | Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire? | mITT, LOCF | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
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| Secondary | Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner? | mITT, LOCF | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population | While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders) | mITT | Posted | Number | Yes Responders | Week 12 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT | EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness? | mITT, LOCF | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population | PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT | SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Yes Responses | Baseline and Weeks 1-12 |
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| Secondary | Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT | SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Yes Responses | Baseline and Weeks 1-12 |
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| Secondary | Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT | SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Yes Responses | Baseline and Weeks 1-12 |
|
|
Twelve weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Udenafil 50 mg | Udenafil 50 mg tablets | 1 | 147 | 43 | 147 | ||
| EG001 | Udenafil 100 mg | Udenafil 100 mg tablets | 1 | 148 | 51 | 148 | ||
| EG002 | Udenafil 150mg | Udenafil 150mg tablets | 3 | 154 | 49 | 150 | ||
| EG003 | Placebo | Placebo tablets | 1 | 150 | 11 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lung Squamous Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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Not provided
| ID | Term |
|---|---|
| C419664 | udenafil |
Not provided
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607). | ANCOVA | Baseline domain score and pooled site as covariates. | <0.0001 | Difference in LS Means | 5.74 | 2-Sided | 95 | 4.05 | 7.43 | No | Superiority or Other |
| 540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607). | ANCOVA | Baseline domain score and pooled site as covariates. | <0.0001 | Difference in LS Means | 7.53 | 2-Sided | 95 | 5.86 | 9.20 | No | Superiority or Other |
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