Benign Prostatic HyperplasiaPhase 2/3NCT00384930

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

A Phase 2/3 study testing tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 1 site in United States.

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

This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms. 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: 1,058 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Oct 2008
Phase: Phase 2/3
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

Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.

Who cannot join

History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
Nitrate use

Trial locations and contacts

1 site in 1 country.

United States1 site

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.
Greenwood, Indiana

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About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions: Benign Prostatic Hyperplasia
Being tested: tadalafil, placebo
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, IC351
2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
tadalafilDrug
Also called LY450190, Cialis, IC351
5 mg tadalafil tablet by mouth once a day for twelve weeks.
tadalafilDrug
Also called LY450190, Cialis, IC351
10 mg tadalafil tablet by mouth once a day for twelve weeks.
tadalafilDrug
Also called LY450190, Cialis, IC351
20 mg tadalafil tablet by mouth once a day for twelve weeks.
placeboDrug
Placebo tablet taken by mouth one a day for twelve weeks

Study groups in NCT00384930
Study group	Role	What they receive
1	Placebo comparator	placebo tablet Receives: Drug: placebo
2	Active comparator	2.5 mg tadalafil tablet Receives: Drug: tadalafil
3	Active comparator	5 mg tadalafil tablet Receives: Drug: tadalafil
4	Active comparator	10 mg tadalafil tablet Receives: Drug: tadalafil
5	Active comparator	20 mg tadalafil tablet Receives: Drug: tadalafil

What is being measured

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

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Measured: Baseline and 12 weeks
Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Measured: Baseline and 12 weeks

Secondary outcomes (8)

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore
Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Measured: 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)
Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)
Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.
Measured: baseline and 12 weeks
Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.
Measured: 12 weeks
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow
Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain
Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Measured: baseline and 12 weeks

Timeline

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

Aug 2006Oct 2008

First posted6 Oct 2006 (estimated)
Study startAug 2006
Primary completionOct 2007
Study completionOct 2008

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.
Publications (4)Papers the sponsor has linked to this study.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,058 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00384930
Sponsor's protocol ID: 9797
Other IDs: H6D-MC-LVHG
Status last verified: Aug 2009
First submitted: 3 Oct 2006
Last updated: 2 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
PubMed 26299520
Broderick GA, Brock GB, Roehrborn CG, Watts SD, Elion-Mboussa A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology. 2010 Jun;75(6):1452-8. doi: 10.1016/j.urology.2009.09.093. Epub 2010 Feb 16.
PubMed 20163842
Porst H, McVary KT, Montorsi F, Sutherland P, Elion-Mboussa A, Wolka AM, Viktrup L. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009 Oct;56(4):727-35. doi: 10.1016/j.eururo.2009.04.033. Epub 2009 Apr 22.
PubMed 19409693
Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008 Oct;180(4):1228-34. doi: 10.1016/j.juro.2008.06.079. Epub 2008 Aug 22.
PubMed 18722631

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

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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT00384930
Acronym / sponsor ID: 9797
Conditions: Benign Prostatic Hyperplasia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,058 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: ICOS Corporation
Study start: Aug 2006
Primary completion: Oct 2007 (actual)
Study completion: Oct 2008 (actual)
First posted: 6 Oct 2006 (estimated)
Results: Posted 19 Aug 2009

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: 5

Arm	Type	Receives
1	Placebo comparator	Drug: placeboplacebo tablet
2	Active comparator	Drug: tadalafil2.5 mg tadalafil tablet
3	Active comparator	Drug: tadalafil5 mg tadalafil tablet
4	Active comparator	Drug: tadalafil10 mg tadalafil tablet
5	Active comparator	Drug: tadalafil20 mg tadalafil tablet

Who may qualify

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

Key inclusion criteria (4 listed)

Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.

Key exclusion criteria (5 listed)

History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
Nitrate use

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, Cialis, IC3512.5 mg tadalafil tablet by mouth once a day for twelve weeks.	Drug	2
tadalafilAlso: LY450190, Cialis, IC3515 mg tadalafil tablet by mouth once a day for twelve weeks.	Drug	3
tadalafilAlso: LY450190, Cialis, IC35110 mg tadalafil tablet by mouth once a day for twelve weeks.	Drug	4
tadalafilAlso: LY450190, Cialis, IC35120 mg tadalafil tablet by mouth once a day for twelve weeks.	Drug	5
placeboPlacebo tablet taken by mouth one a day for twelve weeks	Drug	1

Primary outcome

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
Time frame: Baseline and 12 weeks
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis
Time frame: Baseline and 12 weeks
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.

8 secondary outcomes

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Time frame: 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)
Time frame: baseline and 12 weeks
Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
Time frame: 12 weeks
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 19 Aug 2009, 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	212	185
2.5 mg Tadalafil	209	182
5 mg Tadalafil	212	182
10 mg Tadalafil	216	175
20 mg Tadalafil	209	162

Primary outcome: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 205	5 mg Tadalafil n = 205
Baseline	17.08 (6.36)	17.30 (5.97)
Change from Baseline	-2.25 (6.17)	-4.92 (5.67)

Placebo vs 5 mg Tadalafil: p <0.001, Permutation Test

Population analysed: Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.

Primary outcome: Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 205	2.5 mg Tadalafil n = 201	5 mg Tadalafil n = 205	10 mg Tadalafil n = 207	20 mg Tadalafil n = 199
Value	-2.23 (0.49)	-3.81 (0.50)	-4.83 (0.49)	-5.13 (0.48)	-5.17 (0.50)

Placebo vs 2.5 mg Tadalafil: Mean Difference (Net): -1.58 (95% CI -2.68 to -0.48), p = 0.005, ANCOVA
Placebo vs 5 mg Tadalafil: Mean Difference (Net): -2.60 (95% CI -3.69 to -1.51), p <0.001, ANCOVA
Placebo vs 10 mg Tadalafil: Mean Difference (Net): -2.90 (95% CI -3.99 to -1.81), p <0.001, ANCOVA

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of ?	43 of ?	Not reported
2.5 mg Tadalafil	3 of ?	54 of ?	Not reported
5 mg Tadalafil	1 of ?	65 of ?	Not reported
10 mg Tadalafil	2 of ?	75 of ?	Not reported
20 mg Tadalafil	5 of ?	80 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26299520Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
Derived from this study: PubMed 20163842Broderick GA, Brock GB, Roehrborn CG, Watts SD, Elion-Mboussa A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology. 2010 Jun;75(6):1452-8. doi: 10.1016/j.urology.2009.09.093. Epub 2010 Feb 16.
Derived from this study: PubMed 19409693Porst H, McVary KT, Montorsi F, Sutherland P, Elion-Mboussa A, Wolka AM, Viktrup L. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009 Oct;56(4):727-35. doi: 10.1016/j.eururo.2009.04.033. Epub 2009 Apr 22.
Derived from this study: PubMed 18722631Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008 Oct;180(4):1228-34. doi: 10.1016/j.juro.2008.06.079. Epub 2008 Aug 22.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Benign Prostatic Hyperplasia

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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 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 1 site in United States.

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 4 inclusion and 5 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 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Aug 2009). 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?

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00384930, which also lists 4 linked publications.

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 2 Sep 2009.