A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00848081
First received: February 19, 2009
Last updated: August 16, 2010
Last verified: August 2010

February 19, 2009
August 16, 2010
March 2009
December 2009   (final data collection date for primary outcome measure)
Number of Men With Treatment-emergent Dizziness [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: Yes ]
The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.
The proportion of men with treatment-emergent dizziness. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00848081 on ClinicalTrials.gov Archive Site
  • Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: Yes ]
    A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.
  • International Prostate Symptom Score (IPSS) Change From Baseline [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in IPSS Score. 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.
  • Postvoid Residual Volume (PVR) Change From Baseline [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: Yes ]
    Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.
  • Uroflowmetry (Qmax) Change From Baseline [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: Yes ]
    Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).
  • Orthostatic vital signs [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
  • Postvoid residual volume (PVR) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]
  • Uroflowmetry (Qmax) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • Drug: Tadalafil
    5 mg taken by mouth once daily for 12 weeks
    Other Names:
    • LY450190
    • Cialis
  • Drug: Placebo
    By mouth once daily for 12 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Tadalafil
    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
318
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
  • Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

    1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
    2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
    3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  • If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria:

  • Currently receiving alpha-blocker therapy for the treatment of hypertension.
  • History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
  • Treated with nitrates for any cardiac conditions.
  • Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
  • Have problems with kidneys, liver, or nervous system
  • Have uncontrolled diabetes
  • Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
  • Have had a stroke or a significant injury to brain or spinal cord.
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00848081
11668, H6D-MC-LVHS
No
Chief medical officer, Eli Lilly
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 hourse, EST) Eli Lilly and Company
Eli Lilly and Company
August 2010

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