Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783094
• Other study ID #: 12757
• Secondary ID: H6D-JE-LVIA
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2008
• Last updated: March 18, 2011
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: March 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: April 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.

• Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or 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 Visit 2.

Exclusion Criteria:

• Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.

• History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.

• History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.

• Clinical evidence of prostate cancer at Visit 1.

• Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.

• 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 (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.

• Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tadalafil 2.5 mg
oral, daily
• Tadalafil 5 mg
oral, daily
• Placebo
oral, daily

Locations

Country	Name	City	State
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.	Chiba
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.	Hiroshima
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.	Kanagawa
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.	Kyoto
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint	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.	Baseline, 12 weeks	No
Secondary	Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint	IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.	Baseline, 12 weeks	No
Secondary	Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint	IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.	Baseline, 12 weeks	No
Secondary	Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint	Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).	Baseline, 12 weeks	No
Secondary	Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint	The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.	Baseline, 12 weeks	No
Secondary	Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint	Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).	Baseline, 12 weeks	No
Secondary	Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement	Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.	Baseline, 12 weeks	No
Secondary	Number of Participants With Adverse Events During 12 Weeks of the Study	A listing of Adverse Events are reported in the Reported Adverse Event Section.	Baseline through 12 weeks	Yes
Secondary	Change From Baseline in Blood Pressure at 12-Week Endpoint		Baseline, 12 weeks	Yes
Secondary	Change From Baseline in Sitting Heart Rate at 12-Week Endpoint		Baseline, 12 Weeks	Yes
Secondary	Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint	Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.	Baseline, 12 weeks	Yes
Secondary	Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint	Measurement of nanograms of PSA per milliliter (ng/mL) of blood.	Baseline, 12 weeks	Yes
Secondary	Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint	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.	Baseline, 54 weeks	No
Secondary	Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint	IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.	Baseline, 54 weeks	No
Secondary	Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint	IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.	Baseline, 54 weeks	No
Secondary	Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint	Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).	Baseline, 54 weeks	No
Secondary	Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint	The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.	Baseline, 54 weeks	No
Secondary	Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint	Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).	Baseline, 54 weeks	No
Secondary	Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment	A listing of Adverse Events are reported in the Reported Adverse Event Section.	End of 12 weeks of double-blind through 54 weeks	Yes
Secondary	Change From Baseline in Blood Pressure During at 54-Week Endpoint		Baseline, 54 weeks	Yes
Secondary	Change From Baseline in Sitting Heart Rate at 54-Week Endpoint		Baseline, 54-weeks	Yes
Secondary	Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint	Measurement of nanograms of PSA per milliliter (ng/mL) of blood.	Baseline, 54 weeks	Yes
Secondary	Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint	Post residual volume (PVR) is measured by ultrasound at regular intervals.	Baseline, 54 weeks	Yes