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A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00848081
Collaborator
(none)
318
Enrollment
31
Locations
2
Arms
9
Duration (Months)
10.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
318 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
By mouth once daily for 12 weeks
Experimental: Tadalafil

Drug: Tadalafil
5 mg taken by mouth once daily for 12 weeks
Other Names:
  • LY450190
  • Cialis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Men With Treatment-emergent Dizziness [Baseline through 12 Weeks]

      The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.

    Secondary Outcome Measures

    1. Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit [Baseline through 12 Weeks]

      A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.

    2. International Prostate Symptom Score (IPSS) Change From Baseline [Baseline, 12 Weeks]

      Change from baseline to endpoint in IPSS Score. 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.

    3. Postvoid Residual Volume (PVR) Change From Baseline [Baseline, 12 Weeks]

      Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.

    4. Uroflowmetry (Qmax) Change From Baseline [Baseline, 12 Weeks]

      Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.

    • Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

    1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.

    2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.

    3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.

    • If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.
    Exclusion Criteria:

    • Currently receiving alpha-blocker therapy for the treatment of hypertension.

    • History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.

    • Treated with nitrates for any cardiac conditions.

    • Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).

    • Have problems with kidneys, liver, or nervous system

    • Have uncontrolled diabetes

    • Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).

    • Have had a stroke or a significant injury to brain or spinal cord.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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. Huntsville Alabama United States 35801
    2 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. Anchorage Alaska United States 99508
    3 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. Anaheim California United States 92801
    4 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. Los Angeles California United States 90017
    5 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. Paramount California United States 90723
    6 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. San Diego California United States 92120
    7 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. Vacaville California United States 95688
    8 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. Melbourne Florida United States 32901
    9 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. Orlando Florida United States 32803
    10 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. Pembroke Pines Florida United States 33024
    11 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. St. Petersburg Florida United States 33710
    12 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. West Palm Beach Florida United States 33407
    13 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. Indianapolis Indiana United States 46254
    14 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. St. Clair Shores Michigan United States 48081
    15 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. Missoula Montana United States 59802
    16 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. Albuquerque New Mexico United States 87109
    17 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. Bayshore New York United States 11706
    18 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. Garden City New York United States 11530
    19 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. New York New York United States 10016
    20 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. Poughkeepsie New York United States 12601
    21 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. Concord North Carolina United States 28025
    22 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. Salisbury North Carolina United States 28144
    23 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. Winston-Salem North Carolina United States 27103
    24 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. Edmond Oklahoma United States 73034
    25 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. Dallas Texas United States 75231
    26 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. San Antonio Texas United States 78229
    27 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. Salt Lake City Utah United States 84102
    28 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. Menomonee Falls Wisconsin United States 53051
    29 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. Bayamon Puerto Rico 00961-7049
    30 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. San Juan Puerto Rico 00921-3201
    31 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. Santurce Puerto Rico 00907

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM- 5 PM Eastern time (UTC/GMT -5 hourse, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00848081
    Other Study ID Numbers:
    • 11668
    • H6D-MC-LVHS
    First Posted:
    Feb 20, 2009
    Last Update Posted:
    Sep 14, 2010
    Last Verified:
    Aug 1, 2010
    Keywords provided by , ,
    Prostate
    BPH
    Benign Prostatic Hyperplasia
    BPH-LUTS
    LUTS
    Phosphodiesterase Inhibitors
    tadalafil
    alpha blockers
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tadalafil

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    Period Title: Overall Study
    STARTED 160 158
    COMPLETED 140 140
    NOT COMPLETED 20 18

    Baseline Characteristics

    Arm/Group Title Placebo Tadalafil Total
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks Total of all reporting groups
    Overall Participants 160 158 318
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.35
    (9.13)
    67.41
    (9.11)
    67.38
    (9.10)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    160
    100%
    158
    100%
    318
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    18
    11.3%
    20
    12.7%
    38
    11.9%
    Not Hispanic or Latino
    142
    88.8%
    138
    87.3%
    280
    88.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.6%
    0
    0%
    1
    0.3%
    Asian
    1
    0.6%
    1
    0.6%
    2
    0.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    0.6%
    1
    0.3%
    Black or African American
    14
    8.8%
    17
    10.8%
    31
    9.7%
    White
    144
    90%
    137
    86.7%
    281
    88.4%
    More than one race
    0
    0%
    2
    1.3%
    2
    0.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    157
    98.1%
    148
    93.7%
    305
    95.9%
    Puerto Rico
    3
    1.9%
    10
    6.3%
    13
    4.1%

    Outcome Measures

    1. Primary Outcome
    Title Number of Men With Treatment-emergent Dizziness
    Description The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.
    Time Frame Baseline through 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    Measure Participants 159 158
    Number [Participants]
    9
    5.6%
    11
    7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.403
    Comments 1-sided test
    Method Fisher Exact
    Comments
    2. Secondary Outcome
    Title Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit
    Description A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.
    Time Frame Baseline through 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects in the analysis population with non-missing data.
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    Measure Participants 158 156
    Positive Pre-Random. to Negative Post-Random.
    22
    13.8%
    15
    9.5%
    Negative Pre-Random. to Positive Post-Random.
    21
    13.1%
    19
    12%
    Positive Pre-Random. to Positive Post-Random.
    14
    8.8%
    16
    10.1%
    Negative Pre-Random. to Negative Post-Random.
    101
    63.1%
    106
    67.1%
    3. Secondary Outcome
    Title International Prostate Symptom Score (IPSS) Change From Baseline
    Description Change from baseline to endpoint in IPSS Score. 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.
    Time Frame Baseline, 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    Measure Participants 156 156
    Baseline
    13.3
    (6.57)
    13.87
    (7.15)
    Change from Baseline
    -1.49
    (5.29)
    -2.28
    (5.65)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.130
    Comments p-value is on change from baseline
    Method ANCOVA
    Comments
    4. Secondary Outcome
    Title Postvoid Residual Volume (PVR) Change From Baseline
    Description Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.
    Time Frame Baseline, 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects who had non-missing baseline and endpoint data.
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    Measure Participants 150 151
    Baseline values
    70.7
    (74.87)
    80.3
    (80.78)
    Change from Baseline
    -1.9
    (82.86)
    -8.1
    (88.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.258
    Comments p-value is on change from baseline
    Method ANOVA
    Comments The p-value is from Type III sums of squares ANOVA on rank-transformed data.
    5. Secondary Outcome
    Title Uroflowmetry (Qmax) Change From Baseline
    Description Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).
    Time Frame Baseline, 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects with non-missing data.
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    Measure Participants 115 115
    Baseline
    12.8
    (5.88)
    11.8
    (4.93)
    Change from Baseline
    0.6
    (4.03)
    0.6
    (3.67)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.828
    Comments
    Method ANOVA
    Comments P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.

    Adverse Events

    Time Frame Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
    Adverse Event Reporting Description
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo by mouth once daily for 12 weeks Tadalafil 5 mg taken by mouth once daily for 12 weeks
    All Cause Mortality
    Placebo Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/160 (1.9%) 2/158 (1.3%)
    Gastrointestinal disorders
    Mallory-Weiss syndrome 0/160 (0%) 0 1/158 (0.6%) 1
    General disorders
    Non-cardiac chest pain 1/160 (0.6%) 1 0/158 (0%) 0
    Injury, poisoning and procedural complications
    Fall 1/160 (0.6%) 1 1/158 (0.6%) 1
    Hip fracture 1/160 (0.6%) 1 0/158 (0%) 0
    Lead dislodgement 1/160 (0.6%) 1 0/158 (0%) 0
    Tendon rupture 0/160 (0%) 0 1/158 (0.6%) 1
    Other (Not Including Serious) Adverse Events
    Placebo Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 53/160 (33.1%) 65/158 (41.1%)
    Blood and lymphatic system disorders
    Anaemia 1/160 (0.6%) 1 0/158 (0%) 0
    Leukopenia 0/160 (0%) 0 1/158 (0.6%) 1
    Cardiac disorders
    Atrial fibrillation 0/160 (0%) 0 1/158 (0.6%) 1
    Ear and labyrinth disorders
    Cerumen impaction 0/160 (0%) 0 1/158 (0.6%) 1
    Deafness 0/160 (0%) 0 1/158 (0.6%) 1
    Ear congestion 0/160 (0%) 0 1/158 (0.6%) 1
    Hypoacusis 0/160 (0%) 0 1/158 (0.6%) 1
    Middle ear effusion 0/160 (0%) 0 1/158 (0.6%) 1
    Vertigo 0/160 (0%) 0 1/158 (0.6%) 2
    Eye disorders
    Conjunctivitis 1/160 (0.6%) 1 0/158 (0%) 0
    Eye haemorrhage 0/160 (0%) 0 1/158 (0.6%) 1
    Eye swelling 0/160 (0%) 0 1/158 (0.6%) 1
    Vision blurred 1/160 (0.6%) 1 2/158 (1.3%) 3
    Visual acuity reduced 1/160 (0.6%) 1 0/158 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 0/160 (0%) 0 1/158 (0.6%) 1
    Abdominal pain 1/160 (0.6%) 1 0/158 (0%) 0
    Abdominal pain upper 0/160 (0%) 0 1/158 (0.6%) 1
    Constipation 2/160 (1.3%) 2 0/158 (0%) 0
    Diarrhoea 2/160 (1.3%) 2 5/158 (3.2%) 5
    Dry mouth 1/160 (0.6%) 1 1/158 (0.6%) 1
    Duodenitis 0/160 (0%) 0 1/158 (0.6%) 1
    Dyspepsia 0/160 (0%) 0 8/158 (5.1%) 9
    Eructation 0/160 (0%) 0 1/158 (0.6%) 1
    Flatulence 1/160 (0.6%) 1 0/158 (0%) 0
    Gastritis 1/160 (0.6%) 1 0/158 (0%) 0
    Gastrooesophageal reflux disease 1/160 (0.6%) 1 4/158 (2.5%) 4
    Gingival disorder 1/160 (0.6%) 1 0/158 (0%) 0
    Lip blister 0/160 (0%) 0 1/158 (0.6%) 1
    Nausea 2/160 (1.3%) 2 3/158 (1.9%) 4
    Toothache 0/160 (0%) 0 1/158 (0.6%) 1
    General disorders
    Asthenia 2/160 (1.3%) 2 0/158 (0%) 0
    Chest discomfort 0/160 (0%) 0 1/158 (0.6%) 1
    Cyst 1/160 (0.6%) 1 0/158 (0%) 0
    Fatigue 1/160 (0.6%) 1 3/158 (1.9%) 3
    Oedema peripheral 2/160 (1.3%) 2 1/158 (0.6%) 1
    Suprapubic pain 0/160 (0%) 0 1/158 (0.6%) 1
    Temperature intolerance 0/160 (0%) 0 1/158 (0.6%) 1
    Hepatobiliary disorders
    Cholecystitis 1/160 (0.6%) 1 0/158 (0%) 0
    Immune system disorders
    Seasonal allergy 0/160 (0%) 0 1/158 (0.6%) 1
    Infections and infestations
    Diverticulitis 1/160 (0.6%) 1 1/158 (0.6%) 1
    Ear infection 1/160 (0.6%) 1 0/158 (0%) 0
    Eye infection 0/160 (0%) 0 2/158 (1.3%) 2
    Gastroenteritis 0/160 (0%) 0 1/158 (0.6%) 1
    Gastroenteritis viral 0/160 (0%) 0 1/158 (0.6%) 1
    Gastrointestinal infection 1/160 (0.6%) 1 0/158 (0%) 0
    Herpes zoster 1/160 (0.6%) 1 0/158 (0%) 0
    Lower respiratory tract infection 1/160 (0.6%) 1 0/158 (0%) 0
    Nasopharyngitis 1/160 (0.6%) 1 1/158 (0.6%) 1
    Oral herpes 1/160 (0.6%) 1 0/158 (0%) 0
    Pneumonia 2/160 (1.3%) 2 1/158 (0.6%) 1
    Sinusitis 2/160 (1.3%) 3 1/158 (0.6%) 1
    Tinea infection 1/160 (0.6%) 1 0/158 (0%) 0
    Upper respiratory tract infection 3/160 (1.9%) 3 0/158 (0%) 0
    Urinary tract infection 0/160 (0%) 0 1/158 (0.6%) 1
    Injury, poisoning and procedural complications
    Arthropod bite 1/160 (0.6%) 1 0/158 (0%) 0
    Facial bones fracture 1/160 (0.6%) 1 0/158 (0%) 0
    Procedural pain 1/160 (0.6%) 1 0/158 (0%) 0
    Rib fracture 2/160 (1.3%) 2 0/158 (0%) 0
    Road traffic accident 1/160 (0.6%) 1 0/158 (0%) 0
    Stress fracture 1/160 (0.6%) 1 0/158 (0%) 0
    Whiplash injury 1/160 (0.6%) 1 0/158 (0%) 0
    Investigations
    Blood creatine phosphokinase increased 2/160 (1.3%) 2 0/158 (0%) 0
    Blood pressure decreased 0/160 (0%) 0 1/158 (0.6%) 1
    Blood uric acid increased 1/160 (0.6%) 1 0/158 (0%) 0
    Colonoscopy 3/160 (1.9%) 3 0/158 (0%) 0
    Creatinine renal clearance decreased 1/160 (0.6%) 1 0/158 (0%) 0
    Electrocardiogram abnormal 1/160 (0.6%) 1 0/158 (0%) 0
    Heart rate increased 0/160 (0%) 0 1/158 (0.6%) 1
    Oesophagogastroduodenoscopy 0/160 (0%) 0 1/158 (0.6%) 1
    Metabolism and nutrition disorders
    Dehydration 0/160 (0%) 0 1/158 (0.6%) 1
    Hyperkalaemia 1/160 (0.6%) 1 0/158 (0%) 0
    Hypertriglyceridaemia 0/160 (0%) 0 1/158 (0.6%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/160 (0.6%) 1 1/158 (0.6%) 1
    Back pain 2/160 (1.3%) 2 4/158 (2.5%) 4
    Joint swelling 2/160 (1.3%) 2 1/158 (0.6%) 1
    Loose body in joint 0/160 (0%) 0 1/158 (0.6%) 1
    Muscle spasms 0/160 (0%) 0 1/158 (0.6%) 1
    Muscle tightness 0/160 (0%) 0 1/158 (0.6%) 1
    Myalgia 2/160 (1.3%) 2 0/158 (0%) 0
    Myositis 1/160 (0.6%) 1 0/158 (0%) 0
    Neck pain 0/160 (0%) 0 2/158 (1.3%) 2
    Osteopenia 1/160 (0.6%) 1 0/158 (0%) 0
    Pain in extremity 0/160 (0%) 0 1/158 (0.6%) 1
    Nervous system disorders
    Dizziness 8/160 (5%) 10 10/158 (6.3%) 14
    Dizziness postural 1/160 (0.6%) 1 1/158 (0.6%) 1
    Headache 3/160 (1.9%) 3 2/158 (1.3%) 2
    Nerve compression 0/160 (0%) 0 1/158 (0.6%) 1
    Psychomotor hyperactivity 0/160 (0%) 0 1/158 (0.6%) 1
    Syncope 1/160 (0.6%) 1 0/158 (0%) 0
    Tension headache 0/160 (0%) 0 1/158 (0.6%) 1
    Psychiatric disorders
    Abnormal dreams 1/160 (0.6%) 1 0/158 (0%) 0
    Anxiety 1/160 (0.6%) 1 0/158 (0%) 0
    Insomnia 1/160 (0.6%) 1 1/158 (0.6%) 1
    Renal and urinary disorders
    Dysuria 1/160 (0.6%) 3 1/158 (0.6%) 1
    Nephrolithiasis 0/160 (0%) 0 1/158 (0.6%) 1
    Nocturia 2/160 (1.3%) 2 1/158 (0.6%) 1
    Pollakiuria 3/160 (1.9%) 4 1/158 (0.6%) 1
    Urinary retention 1/160 (0.6%) 1 1/158 (0.6%) 1
    Urine flow decreased 1/160 (0.6%) 1 1/158 (0.6%) 1
    Reproductive system and breast disorders
    Erectile dysfunction 0/160 (0%) 0 1/158 (0.6%) 1
    Genital discomfort 0/160 (0%) 0 1/158 (0.6%) 1
    Prostatitis 2/160 (1.3%) 2 0/158 (0%) 0
    Testicular mass 0/160 (0%) 0 1/158 (0.6%) 1
    Testicular pain 1/160 (0.6%) 1 1/158 (0.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 1/160 (0.6%) 1 0/158 (0%) 0
    Dry throat 0/160 (0%) 0 1/158 (0.6%) 1
    Dyspnoea 0/160 (0%) 0 2/158 (1.3%) 2
    Epistaxis 0/160 (0%) 0 1/158 (0.6%) 1
    Nasal congestion 3/160 (1.9%) 3 1/158 (0.6%) 1
    Oropharyngeal pain 0/160 (0%) 0 2/158 (1.3%) 2
    Rhinitis allergic 1/160 (0.6%) 1 0/158 (0%) 0
    Sinus congestion 0/160 (0%) 0 1/158 (0.6%) 1
    Skin and subcutaneous tissue disorders
    Dermatitis contact 1/160 (0.6%) 1 0/158 (0%) 0
    Night sweats 0/160 (0%) 0 1/158 (0.6%) 1
    Rash 0/160 (0%) 0 2/158 (1.3%) 2
    Surgical and medical procedures
    Colon polypectomy 1/160 (0.6%) 1 0/158 (0%) 0
    Rotator cuff repair 0/160 (0%) 0 1/158 (0.6%) 1
    Skin lesion excision 0/160 (0%) 0 1/158 (0.6%) 1
    Skin neoplasm excision 1/160 (0.6%) 1 0/158 (0%) 0
    Tooth extraction 1/160 (0.6%) 1 0/158 (0%) 0
    Vascular disorders
    Flushing 0/160 (0%) 0 1/158 (0.6%) 1
    Orthostatic hypotension 1/160 (0.6%) 1 0/158 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00848081
    Other Study ID Numbers:
    • 11668
    • H6D-MC-LVHS
    First Posted:
    Feb 20, 2009
    Last Update Posted:
    Sep 14, 2010
    Last Verified:
    Aug 1, 2010