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
  Purpose

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).


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Tadalafil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 318
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
By mouth once daily for 12 weeks
Experimental: Tadalafil Drug: Tadalafil
5 mg taken by mouth once daily for 12 weeks
Other Names:
  • LY450190
  • Cialis

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848081

  Show 31 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Chief medical officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00848081     History of Changes
Other Study ID Numbers: 11668, H6D-MC-LVHS
Study First Received: February 19, 2009
Results First Received: August 16, 2010
Last Updated: August 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Prostate
BPH
Benign Prostatic Hyperplasia
BPH-LUTS
LUTS
Phosphodiesterase Inhibitors
tadalafil
alpha blockers

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic alpha-Antagonists
Phosphodiesterase Inhibitors
Tadalafil
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Enzyme Inhibitors
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014