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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014