Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004062

Trial Description

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Title

A Study to Evaluate the Pharmacokinetics of Tadalafil Administered Once Daily in Japanese and Non-Japanese Subjects With Benign Prostatic Hyperplasia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004062
  •   2012/10/30
  •   2010/08/13
  •   no
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Secondary IDs

  •   NCT01183650  (ClinicalTrials.gov)
  •   13910  (Eli Lilly and Company)
  •   H6D-MC-LVIY 
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Tadalafil
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Characteristics

  •   Interventional
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  •   Open (masking not used)
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  •   Basic research/physiological study
  •   Parallel
  •   I
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Primary Outcome

- Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710; time frame: 1 day and 10 days; 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
- Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710; time frame: 1 day and 10 days

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/07/31
  •   24
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Inclusion Criteria

  •   Male
  •   45   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Eli Lilly and Company
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    • Eli Lilly and Company
    • 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) 
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    • Eli Lilly and Company
    • 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) 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2011/04/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.