A Study of Tadalafil in Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01183650
First received: August 13, 2010
Last updated: April 19, 2012
Last verified: April 2012

August 13, 2010
April 19, 2012
July 2010
April 2011   (final data collection date for primary outcome measure)
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710 [ Time Frame: 1 day and 10 days ] [ Designated as safety issue: No ]
    AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.
  • Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710 [ Time Frame: 1 day and 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710 [ Time Frame: 1 day and 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: 1 day, 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics, concentration maximum (Cmax) [ Time Frame: 1 day, 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time to concentration maximum (tmax) [ Time Frame: 1 day, 10 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01183650 on ClinicalTrials.gov Archive Site
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Not Provided
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A Study of Tadalafil in Benign Prostatic Hyperplasia
A Study to Evaluate the Pharmacokinetics of Tadalafil Administered Once Daily in Japanese and Non-Japanese Subjects With Benign Prostatic Hyperplasia

The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH).

The safety of tadalafil will also be studied.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Benign Prostatic Hyperplasia
Drug: Tadalafil
5 mg, administered orally, daily for 10 days
Other Names:
  • LY450190
  • Cialis
  • Adcirca
Experimental: Tadalafil
5 mg, administered orally, daily for 10 days
Intervention: Drug: Tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have had lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) (as diagnosed by a qualified physician) >6 months at screening visit. Lower urinary tract symptoms (LUTS) include those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining) and/or storage (irritative symptoms, such as frequency, urgency, nocturia).
  • Have BPH-LUTS with moderate-to-severe symptoms confirmed by an International Prostate Symptom Score (IPSS) >12. (The IPSS total score is defined as the sum of Questions 1 through 7 and does not include the IPSS Quality of Life.)
  • Taking into account the age and disease status, subjects determined to be in good health according to medical history, physical examination, electrocardiogram (ECG), and laboratory safety assessments.
  • Body mass index between 18 and 30 kg/m^2 inclusive.
  • Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments, including alpha blockers, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at least 1 week prior to dosing and through to follow-up.
  • Subjects with a serum prostate-specific antigen (PSA) <10.0 ng/mL. Subjects with a serum PSA greater than or equal to 4.0 and <10.0 ng/mL must have documentation of a negative histologic biopsy of carcinoma of the prostate within 12 months prior to screening.

Exclusion Criteria:

  • History of radical prostatectomy, or other pelvic surgery or procedure, including any pelvic surgical procedure on the urinary tract apart from transurethral resection, pelvic surgery for malignancy or bowel resection, or a history of lower urinary tract malignancy or trauma. History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening.
  • Current or previous history of malignant disease of the prostate.
  • Concomitant treatment with or ingestion of cytochrome P 450 3A4 (CYP3A4)-inducing or -inhibiting agents from 2 weeks prior to dosing and through the end of the study. Including herbal/food and other supplements, fruit, or fruit juices containing grapefruit or pomegranate components.
  • History of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
  • Subjects with chronic stable angina treated with long-acting nitrates, subjects with chronic stable angina who required short-acting nitrates in the 90 days prior to screening visit, or subjects with angina occurring during sexual intercourse in the 6 months prior to screening.
  • Subjects having met the criteria for unstable angina within 6 months prior to screening, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days prior to screening.
  • Any evidence of heart disease (New York Heart Association [NYHA] greater than or equal to Class III) within 6 months of screening.
  • A history of cardiac arrest.
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01183650
13910, H6D-MC-LVIY
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP