Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)

NCT01460342 | Completed Phase 3 Results

• 2 other identifiers: 14101H6D-JE-LVJF
• Study Type: interventional
• Target: 610
• Locations: 2 countries
• Sites: 17

Brief Summary

This is a phase 3, randomized, double-blind, placebo-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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Prostatic hyperplasia; Benign prostatic hyperplasia; Lower urinary tract

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks

  The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.

  Baseline, 12 weeks

Secondary Outcomes (7)

• Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)

  Baseline, 4 weeks, 8 weeks

• Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks

  12 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Following the 4-week placebo lead-in period, this arm will consist of a 12-week placebo treatment period involving 2 x 2.5-milligram (mg) tadalafil placebo tablets taken orally once daily.

Drug: Placebo

Tadalafil

EXPERIMENTAL

Following the 4-week placebo lead-in period, this arm will consist of a 12-week treatment period involving 2 x 2.5-mg tadalafil tablets taken orally once daily.

Drug: Tadalafil; Drug: Placebo

Interventions

Tadalafil DRUG

5 mg (2 x 2.5-mg tablets), given once daily as oral tablet

Also known as: Cialis, LY450190

Tadalafil

Placebo DRUG

2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily.

Placebo; Tadalafil

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic criteria, at study entry.
• Provide signed informed consent at study entry.
• Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥13 at beginning of placebo lead-in period.
• Have bladder outlet obstruction of intermediate severity as defined by a urinary peak flow rate (Qmax) of ≥4 to ≤15 milliliters per second (mL/sec) \[from a prevoid total bladder volume (assessed by ultrasound) of ≥150 to ≤550 milliliters (mL) and a minimum voided volume of 125 mL\] at beginning of placebo lead-in period.
• Have prostate volume ≥20 mL estimated by transabdominal or transrectal ultrasound at study entry.
• Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and/or overactive bladder (OAB) treatments, including alpha-blockers, 5-alpha reductase inhibitors (5-ARIs), phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study.
• Have not taken the following treatments within the indicated duration:
• Finasteride therapy for at least 3 months prior to beginning of placebo lead-in period.
• Dutasteride therapy for at least 6 months prior to beginning of placebo lead-in period.
• Anti-androgenic hormone therapy at least 12 months prior to beginning of placebo lead-in period.
• All other BPH therapy (including herbal preparations) for at least 4 weeks prior to beginning of placebo lead-in period.
• ED therapy for at least 4 weeks prior to beginning of placebo lead-in period.
• OAB therapy for at least 4 weeks prior to beginning of placebo lead-in period.
• Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering ≥70% of prescribed doses, confirmed by documentation that the participant returned ≤30% of prescribed doses at randomization.

You may not qualify if:

• Prostate-specific antigen (PSA) \>10.0 nanograms per milliliter (ng/mL) at study entry.
• PSA ≥4.0 to ≤10.0 ng/mL at study entry, if prostate malignancy has not been ruled out to the satisfaction of an urologist.
• Bladder postvoid residual (PVR) ≥300 mL by ultrasound determination at study entry.
• History of any of the following pelvic conditions (checked at study entry):
• Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.
• Pelvic radiotherapy.
• Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
• Lower urinary tract malignancy or trauma.
• Lower urinary tract instrumentation (including prostate biopsy) within 30 day of study entry.
• History of urinary retention or lower urinary tract (bladder) stones within 6 months of study entry.
• History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
• Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis) at study entry.
• Clinical evidence of prostate cancer.
• Clinical evidence of any of the following bladder conditions:
• Mullerian duct cysts.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Chiba, 270-0034, Japan

Location

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.

Ehime, 790-0962, Japan

Location

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.

Fukuoka, 816-0943, Japan

Location

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, 650-0012, Japan

Location

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.

Kagoshima, 891-0105, Japan

Location

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, 252-0143, Japan

Location

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, 600-8813, Japan

Location

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, 553-0001, Japan

Location

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.

Saitama, 331-0823, Japan

Location

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, 150-0002, Japan

Location

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.

Yamanashi, 407-0015, Japan

Location

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.

Goyang-si, 412-270, South Korea

Location

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.

Incheon, 400-711, South Korea

Location

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.

Jeonju, 561-712, South Korea

Location

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.

Kwangju, 501-757, South Korea

Location

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.

Pusan, 609 735, South Korea

Location

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.

Seoul, 137-040, South Korea

Location

Related Publications (1)

• Takeda M, Yokoyama O, Lee SW, Murakami M, Morisaki Y, Viktrup L. Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea. Int J Urol. 2014 Jul;21(7):670-5. doi: 10.1111/iju.12410. Epub 2014 Feb 27.

  PMID: 24571205 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 25, 2013
• Results First Posted: September 25, 2013

Record last verified: 2013-07

Locations

KR (6); JP (11)