Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00861757

Purpose

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).

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Tadalafil Drug: Placebo Drug: Tamsulosin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, 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

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Tadalafil

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Patient Global Impression of Improvement (PGI-I) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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).
Clinician Global Impression of Improvement (CGI-I) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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).
Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
Nanograms of PSA per milliliter (ng/mL) of blood.
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.
Change From Baseline in Blood Pressure (Sitting) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Blood Pressure (Standing) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	612
Study Start Date:	March 2009
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo PO, QD (30 min after meal) for 12 weeks
Experimental: 2.5 mg Tadalafil	Drug: Tadalafil by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks Other Name: LY450190, Cialis
Experimental: 5.0 mg Tadalafil	Drug: Tadalafil by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks Other Name: LY450190, Cialis
Active Comparator: 0.2 mg Tamsulosin	Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
Clinical evidence of prostate cancer at initiation
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861757

Locations

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.
Hyogo, Japan, 663-8006
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, Japan, 565-0854
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, Japan, 130-0026
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.
Kaohsiung, Taiwan, 813
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, Taiwan, 100
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.
Tao-Yuan, Taiwan, 333

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 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00861757 History of Changes
Other Study ID Numbers:	10487, H6D-MC-LVHB
Study First Received:	March 12, 2009
Results First Received:	May 10, 2011
Last Updated:	June 23, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency; Korea: Food and Drug Administration; Taiwan: Department of Health

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Tadalafil
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012