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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVHB | Other Identifier | Eli Lilly and Company |
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This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 2.5 mg Tadalafil | Experimental |
| |
| 5.0 mg Tadalafil | Experimental |
| |
| 0.2 mg Tamsulosin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 663-8006 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks |
| FG001 | 2.5 mg Tadalafil | Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks |
| FG002 | 5.0 mg Tadalafil | Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks |
| FG003 | 0.2 mg Tamsulosin | Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks |
| BG001 | 2.5 mg Tadalafil | Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Least Squares Mean | Standard Error | Units on a scale | baseline, 12 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 | Placebo | Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | PO, QD (30 min after meal) for 12 weeks |
|
| Tamsulosin | Drug | PO, QD (30 min after meal) for 12 weeks |
|
| baseline, 12 weeks |
| Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks | Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. | baseline, 12 weeks |
| Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. | baseline, 12 weeks |
| Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks | Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. | baseline, 12 weeks |
| Patient Global Impression of Improvement (PGI-I) at Week 12 | The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | 12 weeks |
| Clinician Global Impression of Improvement (CGI-I) at Week 12 | The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | 12 weeks |
| Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks | Nanograms of PSA per milliliter (ng/mL) of blood. | baseline, 12 weeks |
| Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks | The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound. | baseline, 12 weeks |
| Change From Baseline in Blood Pressure (Sitting) at 12 Weeks | baseline, 12 weeks |
| Change From Baseline in Blood Pressure (Standing) at 12 Weeks | baseline, 12 weeks |
| Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks | baseline, 12 weeks |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 565-0854 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 130-0026 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaohsiung City | 813 | Taiwan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taipei | 100 | Taiwan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taoyuan | 333 | Taiwan |
| Entry Criteria Not Met |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | 5.0 mg Tadalafil | Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks |
| BG003 | 0.2 mg Tamsulosin | Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square meters (kg/m^2) |
|
| Current Tobacco Use | Number | participants |
|
| Current Alcohol Use | Number | participants |
|
| Benign Prostatic Hyperplasia (BPH) Severity | The International Prostate Symptom Score (IPSS) Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | Number | participants |
|
| Duration of BPH | Mean | Standard Deviation | Years |
|
| Patient Global Impressions of Severity Scale (PGI-S) | The Patient Global Impressions of Severity Scale (PGI-S) measures patient's perception of severity of illness prior to clinical assessments during study visits. Scores range from 1 (Normal) to 4 (Severe) where 1=Normal, 2=Mild, 3=Moderate, and 4=Severe. | Number | participants |
|
| Clinical Global Impressions of Severity Scale (CGI-S) | The Clinical Global Impressions of Severity Scale (CGI-S) measures clinician's perception of severity of illness prior to assessments during study visits. Scores range from 1 (Normal) to 4 (Severe) where 1=Normal, 2=Mild, 3=Moderate, and 4=Severe. | Number | participants |
|
| Previous Alpha-Blocker Therapy | Number | participants |
|
| Previous BPH Therapy | Number | participants |
|
| Postvoid Residual Volume (PVR) | Postvoid residual volume (PVR) is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound. | Mean | Standard Deviation | milliliters (mL) |
|
| Prostate Volume | Prostate volume is defined as the volume of prostate estimated by transabdominal or transrectal ultrasound. | Mean | Standard Deviation | mL |
|
| OG001 | 2.5 mg Tadalafil | Drug: Tadalafil PO, QD (30min after meal) for 12 weeks |
| OG002 | 5 mg Tadalafil | Drug: Tadalafil PO, QD (30min after meal) for 12 weeks |
| OG003 | 0.2 mg Tamsulosin | Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks |
|
|
|
| Secondary | Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks | Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks | Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Least Squares Mean | Standard Error | milliliter per second (mL/sec) | baseline, 12 weeks |
|
|
|
|
| Secondary | Patient Global Impression of Improvement (PGI-I) at Week 12 | The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Number | Participants | 12 weeks |
|
|
|
|
| Secondary | Clinician Global Impression of Improvement (CGI-I) at Week 12 | The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks | Nanograms of PSA per milliliter (ng/mL) of blood. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Mean | Standard Deviation | microgram/Liter | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks | The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound. | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Mean | Standard Deviation | milliliter (mL) | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Blood Pressure (Sitting) at 12 Weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Mean | Standard Deviation | mm Hg | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Blood Pressure (Standing) at 12 Weeks | All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication. | Posted | Mean | Standard Deviation | mm Hg | baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Posted | Mean | Standard Deviation | beats per minute (bpm) | baseline, 12 weeks |
|
|
|
|
| 1 |
| 154 |
| 24 |
| 154 |
| EG001 | 2.5 mg Tadalafil | Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks | 4 | 151 | 38 | 151 |
| EG002 | 5.0 mg Tadalafil | Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks | 0 | 155 | 42 | 155 |
| EG003 | 0.2 mg Tamsulosin | Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks | 0 | 152 | 35 | 152 |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Adenoiditis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Hepatitis A | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Transaminases abnormal | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Spontaneous penile erection | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Colon polypectomy | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| D052801 |
| Male Urogenital Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| Storage (Irritative) Score (N = 154,151,155,152) |
|
| 0.005 |
This is the p value for the Voiding (Obstructive) Score. |
| Mean Difference (Final Values) |
| -1.1 |
| Standard Error of the Mean |
| 0.4 |
| 2-Sided |
| 95 |
| -1.9 |
| -0.3 |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | This is the p value for the Voiding (Obstructive) Score. | Mean Difference (Final Values) | -1.9 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -2.7 | -1.1 | No | Superiority or Other |
| ANCOVA | 0.072 | This is the p value for the Storage (Irritative) Score. | Mean Difference (Final Values) | -0.5 | Standard Error of the Mean | 0.3 | 2-Sided | 95 | -1.0 | 0.0 | No | Superiority or Other |
| ANCOVA | 0.021 | This is the p value for the Storage (Irritative) Score. | Mean Difference (Final Values) | -0.6 | Standard Error of the Mean | 0.3 | 2-Sided | 95 | -1.1 | -0.1 | No | Superiority or Other |
| ANCOVA | 0.023 | This is the p value for the Storage (Irritative) Score. | Mean Difference (Final Values) | -0.6 | Standard Error of the Mean | 0.3 | 2-Sided | 95 | -1.1 | -0.1 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -0.3 |
| Standard Error of the Mean |
| 0.1 |
| 2-Sided |
| 95 |
| -0.6 |
| -0.1 |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -0.6 | Standard Error of the Mean | 0.1 | 2-Sided | 95 | -0.9 | -0.4 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -0.2 |
| Standard Error of the Mean |
| 0.3 |
| 2-Sided |
| 95 |
| -0.8 |
| 0.3 |
| No |
| Superiority or Other |
| ANCOVA | 0.007 | Mean Difference (Final Values) | -0.8 | Standard Error of the Mean | 0.3 | 2-Sided | 95 | -1.4 | -0.2 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -0.8 |
| Standard Error of the Mean |
| 0.5 |
| 2-Sided |
| 95 |
| -1.8 |
| 0.3 |
| No |
| Superiority or Other |
| ANCOVA | 0.940 | Mean Difference (Final Values) | -0.0 | Standard Error of the Mean | 0.5 | 2-Sided | 95 | -1.1 | 1.0 | No | Superiority or Other |
| Much Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Much Better |
|
| Very Much Better |
|
| <0.001 |
The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | <0.001 | The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I. | 95 | No | Superiority or Other |
| Much Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Much Better |
|
| Very Much Better |
|
| 0.002 |
The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | 0.001 | The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I. | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.456 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.212 | 95 | No | Superiority or Other |
| Diastolic Blood Pressure |
|
| 0.274 |
This is the p value for systolic blood pressure. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.538 | This is the p value for systolic blood pressure. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.008 | This is the p value for diastolic blood pressure. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.216 | This is the p value for diastolic blood pressure. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.524 | This is the p value for diastolic blood pressure. | 95 | No | Superiority or Other |
| Diastolic Blood Pressure |
|
| 0.723 |
This is the p value for systolic blood pressure. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon rank-sum test | 0.273 | This is the p value for systolic blood pressure. | 95 | No | Superiority or Other |
| Wilcoxon rank-sum test | 0.005 | This is the p value for diastolic blood pressure. | 95 | No | Superiority or Other |
| Wilcoxon rank-sum test | 0.054 | This is the p value for diastolic blood pressure. | 95 | No | Superiority or Other |
| Wilcoxon rank-sum test | 0.278 | This is the p value for diastolic blood pressure. | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon rank-sum test | 0.409 | 95 | No | Superiority or Other |