Benign Prostatic HyperplasiaPhase 3NCT00848081

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

A Phase 3 study testing Tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 318 participants
Where: 31 sitesin 2 countries
Study dates: Mar 2009to Dec 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States28 sites

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.
Albuquerque, New Mexico, 87109
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Anaheim, California, 92801
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Anchorage, Alaska, 99508
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Bay Shore, New York, 11706
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Concord, North Carolina, 28025
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Dallas, Texas, 75231
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Edmond, Oklahoma, 73034
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Garden City, New York, 11530
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46254
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Los Angeles, California, 90017
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Melbourne, Florida, 32901
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Menomonee Falls, Wisconsin, 53051
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Missoula, Montana, 59802
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New York, New York, 10016
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Orlando, Florida, 32803
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Paramount, California, 90723
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Pembroke Pines, Florida, 33024
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Poughkeepsie, New York, 12601
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Saint Clair Shores, Michigan, 48081
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Salisbury, North Carolina, 28144
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Salt Lake City, Utah, 84102
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San Antonio, Texas, 78229
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San Diego, California, 92120
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St. Petersburg, Florida, 33710
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.
Vacaville, California, 95688
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.
West Palm Beach, Florida, 33407
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Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico3 sites

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.
Bayamón, 00961-7049
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San Juan, 00921-3201
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Santurce, 00907

Other trials in Puerto Rico

About this study

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

Conditions: Benign Prostatic Hyperplasia
Being tested: Tadalafil, Placebo
Keywords: Prostate, BPH, Benign Prostatic Hyperplasia, BPH-LUTS, LUTS, Phosphodiesterase Inhibitors, tadalafil, alpha blockers
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TadalafilDrug
Also called LY450190, Cialis
5 mg taken by mouth once daily for 12 weeks
PlaceboDrug
By mouth once daily for 12 weeks

Study groups in NCT00848081
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Tadalafil	Experimental	Not described Receives: Drug: Tadalafil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline through 12 Weeks

Secondary outcomes (4)

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.
Measured: Baseline through 12 Weeks
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.
Measured: Baseline, 12 Weeks
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.
Measured: Baseline, 12 Weeks
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).
Measured: Baseline, 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Dec 2009

First posted20 Feb 2009 (estimated)
Study startMar 2009
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00848081
Sponsor's protocol ID: 11668
Other IDs: H6D-MC-LVHS
Status last verified: Aug 2010
First submitted: 19 Feb 2009
Last updated: 14 Sep 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00848081
Acronym / sponsor ID: 11668
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostate, BPH, Benign Prostatic Hyperplasia, BPH-LUTS, LUTS, Phosphodiesterase Inhibitors, tadalafil, alpha blockers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 20 Feb 2009 (estimated)
Results: Posted 14 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Tadalafil	Experimental	Drug: Tadalafil

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:
If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TadalafilAlso: LY450190, Cialis5 mg taken by mouth once daily for 12 weeks	Drug	Tadalafil
PlaceboBy mouth once daily for 12 weeks	Drug	Placebo

Primary outcome

Number of Men With Treatment-emergent Dizziness
Time frame: Baseline through 12 Weeks
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.

4 secondary outcomes

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
International Prostate Symptom Score (IPSS) Change From Baseline
Time frame: Baseline, 12 Weeks
Postvoid Residual Volume (PVR) Change From Baseline
Time frame: Baseline, 12 Weeks
Uroflowmetry (Qmax) Change From Baseline
Time frame: Baseline, 12 Weeks

Results and safety

Results posted to the registry on 14 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	160	140
Tadalafil	158	140

Primary outcome: Number of Men With Treatment-emergent Dizziness

Time frame: Baseline through 12 Weeks. Number. Unit: Participants

Measure	Placebo n = 159	Tadalafil n = 158
Value	9	11

Placebo vs Tadalafil: p = 0.403, Fisher Exact

Population analysed: Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 160 (1.9%)	53 of 160 (33.1%)	Not reported
Tadalafil	2 of 158 (1.3%)	65 of 158 (41.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Men With Treatment-emergent Dizziness (time frame: Baseline through 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00848081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2010.