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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tadalafil

Placebo

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Prostate, BPH, Benign Prostatic Hyperplasia, BPH-LUTS, LUTS, Phosphodiesterase Inhibitors, tadalafil, alpha blockers

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Tadalafil

Arm Description

Outcomes

Primary Outcome Measures

Number of Men With Treatment-emergent Dizziness

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

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

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

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

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).

Full Information

NCT ID

NCT00848081

First Posted

February 19, 2009

Last Updated

August 16, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00848081

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

Prostate, BPH, Benign Prostatic Hyperplasia, BPH-LUTS, LUTS, Phosphodiesterase Inhibitors, tadalafil, alpha blockers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

318 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Tadalafil

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Tadalafil

Other Intervention Name(s)

LY450190, Cialis

Intervention Description

5 mg taken by mouth once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

By mouth once daily for 12 weeks

Primary Outcome Measure Information:

Title

Number of Men With Treatment-emergent Dizziness

Description

Time Frame

Baseline through 12 Weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit

Description

Time Frame

Baseline through 12 Weeks

Title

International Prostate Symptom Score (IPSS) Change From Baseline

Description

Time Frame

Baseline, 12 Weeks

Title

Postvoid Residual Volume (PVR) Change From Baseline

Description

Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.

Time Frame

Baseline, 12 Weeks

Title

Uroflowmetry (Qmax) Change From Baseline

Description

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).

Time Frame

Baseline, 12 Weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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: All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

City

Vacaville

State/Province

California

ZIP/Postal Code

95688

Country

United States

Facility Name

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

Facility Name

City

St. Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

City

Bayshore

State/Province

New York

ZIP/Postal Code

11706

Country

United States

Facility Name

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

City

Menomonee Falls

State/Province

Wisconsin

ZIP/Postal Code

53051

Country

United States

Facility Name

City

Bayamon

ZIP/Postal Code

00961-7049

Country

Puerto Rico

Facility Name

City

San Juan

ZIP/Postal Code

00921-3201

Country

Puerto Rico

Facility Name

City

Santurce

ZIP/Postal Code

00907

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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