IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

Sponsor
Janssen Biotech, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01314118
Collaborator
(none)
131
Enrollment
45
Locations
1
Arm
158.9
Anticipated Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: abiraterone acetate in combination with prednisone
Phase 2

Detailed Description

This is a Phase 2, prospective, multicenter, open-label, single-arm study of abiraterone acetate plus prednisone in men with non-metastatic, castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. The study consists of Screening Phase (up to 4 weeks), Core Study Treatment Phase (comprised of six 28-day cycles), a Pre-metastatic Disease Follow-up Phase, an Optional Drug Holiday Phase; and a 30-day Safety Follow-up Visit. Each treatment cycle will last 28 days. Participating participants will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. If the partcipants elects to participate in the Optional Drug Holiday Phase, participants will discontinue abiraterone acetate plus prednisone and ADT. Participants will have the option to return to study medication during the first year of the Optional Drug Holiday Phase if there is evidence of rising PSA but no metastasis based on study imaging. If participants do no elect to participate, they will continue with the core study treatment as per protocol. The study will end when all participated participants have disease progression or end of the 2-year period (if participants participated in the Optional Drug Holiday Phase). Participants will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease
Actual Study Start Date :
May 4, 2011
Actual Primary Completion Date :
Dec 24, 2013
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: 001

abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Drug: abiraterone acetate in combination with prednisone
Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study [End of core study visit (Approximately at Month 6)]

    Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.

Secondary Outcome Measures

  1. Time to Radiographic Evidence of Disease Progression (TTRP) [Maximum up to Month 30.5]

    Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.

  2. Time to Prostate-Specific Antigen (PSA) Progression [Maximum up to Month 30.5]

    Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.

  3. Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment [End of Cycle 3 (Approximately Month 3)]

    Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Major Inclusion Criteria:
  • Be a male >= 18 years of age

  • Have adenocarcinoma of the prostate

  • Currently receiving continuous treatment with Gonadotropin-releasing hormone (GnRH) monotherapy for at least 6 months before or have undergone surgical removal of the testicles

  • Serum testosterone of < 50 ng/dL(< 2.0 nM)

  • Have rising PSA defined as a PSA of >= 10 ng/mL obtained at screening or PSADT of ≤ 10 months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0 ng/mL

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

  • Be capable of swallowing study agents whole as a tablet

  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

Major Exclusion Criteria:
  • Have prior or current evidence of local disease progression or metastatic disease as defined by modified response evaluation criteria in solid tumors (RECIST) criteria

  • Have received chemotherapy for treatment of castrate-resistant prostate cancer; however, if a patient received chemotherapy in an adjuvant setting, prior to having CRPC, for castrate-sensitive prostate cancer, the patient is still eligible

  • Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or nilutamide).

  • If previously treated with antiandrogen therapy, there must be documentation of at least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to screening

  • If previously treated with flutamide, at least 1 of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.

  • If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation

  • Have previously received agents having any CYP17 inhibitory activity for the treatment of prostate cancer, such as ketoconazole

  • Have previously received aminoglutethimide

  • Have an active infection or other medical condition that would contraindicate prednisone use

  • Have uncontrolled hypertension

  • Have active hepatitis or chronic liver disease

  • Have clinically significant heart disease

  • Have poorly controlled diabetes

  • Have received an investigational therapeutic within 30 days of screening

  • Have partners of childbearing potential and are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate.

  • Individuals with a history of a non-prostate malignancy are ineligible for this study with the following exceptions. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: basal cell or squamous cell carcinoma of the skin

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1HomewoodAlabamaUnited States
2HuntsvilleAlabamaUnited States
3TucsonArizonaUnited States
4Los AngelesCaliforniaUnited States
5San DiegoCaliforniaUnited States
6San FranciscoCaliforniaUnited States
7AuroraColoradoUnited States
8DenverColoradoUnited States
9AventuraFloridaUnited States
10Orange CityFloridaUnited States
11AtlantaGeorgiaUnited States
12EvanstonIllinoisUnited States
13GalesburgIllinoisUnited States
14GlenviewIllinoisUnited States
15Melrose ParkIllinoisUnited States
16Fort WayneIndianaUnited States
17JeffersonvilleIndianaUnited States
18New OrleansLouisianaUnited States
19BaltimoreMarylandUnited States
20RockvilleMarylandUnited States
21BostonMassachusettsUnited States
22LansingMichiganUnited States
23OmahaNebraskaUnited States
24LawrencevilleNew JerseyUnited States
25AlbanyNew YorkUnited States
26BrooklynNew YorkUnited States
27BuffaloNew YorkUnited States
28Garden CityNew YorkUnited States
29New YorkNew YorkUnited States
30PoughkeepsieNew YorkUnited States
31Staten IslandNew YorkUnited States
32Chapel HillNorth CarolinaUnited States
33RaleighNorth CarolinaUnited States
34CincinnatiOhioUnited States
35ClevelandOhioUnited States
36LancasterPennsylvaniaUnited States
37PhiladelphiaPennsylvaniaUnited States
38PittsburghPennsylvaniaUnited States
39GreenvilleSouth CarolinaUnited States
40Myrtle BeachSouth CarolinaUnited States
41NashvilleTennesseeUnited States
42ArlingtonTexasUnited States
43HoustonTexasUnited States
44SeattleWashingtonUnited States
45MilwaukeeWisconsinUnited States

Sponsors and Collaborators

  • Janssen Biotech, Inc.

Investigators

  • Study Director: Janssen Services, LLC. Clinical Trial, Janssen Biotech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01314118
Other Study ID Numbers:
  • CR017932
  • Protocol 212082PCR2005
First Posted:
Mar 14, 2011
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Biotech, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleAbiraterone Acetate
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Period Title: Overall Study
STARTED131
COMPLETED0
NOT COMPLETED131

Baseline Characteristics

Arm/Group TitleAbiraterone Acetate
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Overall Participants131
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
71.2
(8.82)
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
131
100%
Region of Enrollment (participants) [Number]
USA
131
100%

Outcome Measures

1. Primary Outcome
TitlePercentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
DescriptionPercentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Time FrameEnd of core study visit (Approximately at Month 6)

Outcome Measure Data

Analysis Population Description
Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.
Arm/Group TitleAbiraterone Acetate and Prednisone
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Measure Participants122
Number (95% Confidence Interval) [Percentage of participants]
86.9
66.3%
2. Secondary Outcome
TitleTime to Radiographic Evidence of Disease Progression (TTRP)
DescriptionTime to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.
Time FrameMaximum up to Month 30.5

Outcome Measure Data

Analysis Population Description
All enrolled set included all participants who received at least 1 dose of study drug.
Arm/Group TitleAbiraterone Acetate and Prednisone
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Measure Participants131
Median (95% Confidence Interval) [Months]
NA
3. Secondary Outcome
TitleTime to Prostate-Specific Antigen (PSA) Progression
DescriptionTime to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.
Time FrameMaximum up to Month 30.5

Outcome Measure Data

Analysis Population Description
All enrolled set included all participants who received at least 1 dose of study drug.
Arm/Group TitleAbiraterone Acetate and Prednisone
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Measure Participants131
Median (95% Confidence Interval) [Months]
28.7
4. Secondary Outcome
TitlePercentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
DescriptionPercentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.
Time FrameEnd of Cycle 3 (Approximately Month 3)

Outcome Measure Data

Analysis Population Description
Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.
Arm/Group TitleAbiraterone Acetate and Prednisone
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Measure Participants122
Number (95% Confidence Interval) [Percentage of Participants]
85.2
65%

Adverse Events

Time FrameScreening up to Month 30.5
Adverse Event Reporting Description
Arm/Group TitleAbiraterone Acetate
Arm/Group DescriptionParticipants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
All Cause Mortality
Abiraterone Acetate
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
Abiraterone Acetate
Affected / at Risk (%)# Events
Total50/131 (38.2%)
Blood and lymphatic system disorders
Anaemia1/131 (0.8%)
Cardiac disorders
Acute Myocardial Infarction1/131 (0.8%)
Atrial Fibrillation2/131 (1.5%)
Bradycardia2/131 (1.5%)
Cardio-Respiratory Arrest1/131 (0.8%)
Coronary Artery Disease3/131 (2.3%)
Myocardial Infarction2/131 (1.5%)
Cardiac Failure Congestive1/131 (0.8%)
Ear and labyrinth disorders
Meniere's Disease1/131 (0.8%)
Gastrointestinal disorders
Colitis Ulcerative1/131 (0.8%)
Gastrointestinal Haemorrhage1/131 (0.8%)
Gastrointestinal Pain1/131 (0.8%)
Abdominal Pain1/131 (0.8%)
Obstruction Gastric1/131 (0.8%)
Rectourethral Fistula1/131 (0.8%)
Small Intestinal Obstruction1/131 (0.8%)
General disorders
Chest Pain1/131 (0.8%)
Oedema Peripheral1/131 (0.8%)
Systemic Inflammatory Response Syndrome1/131 (0.8%)
Asthenia1/131 (0.8%)
Infections and infestations
Lobar Pneumonia1/131 (0.8%)
Osteomyelitis1/131 (0.8%)
Pneumonia6/131 (4.6%)
Sepsis4/131 (3.1%)
Urinary Tract Infection1/131 (0.8%)
Urosepsis1/131 (0.8%)
Injury, poisoning and procedural complications
Cystitis Radiation1/131 (0.8%)
Fall2/131 (1.5%)
Femur Fracture1/131 (0.8%)
Spinal Fracture1/131 (0.8%)
Transplant Failure1/131 (0.8%)
Investigations
Alanine Aminotransferase Increased4/131 (3.1%)
Hepatic Enzyme Increased1/131 (0.8%)
Blood Glucose Increased1/131 (0.8%)
Blood Potassium Increased1/131 (0.8%)
Liver Function Test Abnormal2/131 (1.5%)
Metabolism and nutrition disorders
Dehydration3/131 (2.3%)
Electrolyte Imbalance1/131 (0.8%)
Failure to Thrive1/131 (0.8%)
Hyperglycaemia1/131 (0.8%)
Hypokalaemia1/131 (0.8%)
Musculoskeletal and connective tissue disorders
Back Pain1/131 (0.8%)
Flank Pain1/131 (0.8%)
Intervertebral Disc Protrusion1/131 (0.8%)
Muscular Weakness2/131 (1.5%)
Rheumatoid Arthritis1/131 (0.8%)
Lumbar Spinal Stenosis1/131 (0.8%)
Nervous system disorders
Dizziness1/131 (0.8%)
Neurological Symptom1/131 (0.8%)
Presyncope1/131 (0.8%)
Syncope3/131 (2.3%)
Brain Mass1/131 (0.8%)
Renal and urinary disorders
Bladder Obstruction1/131 (0.8%)
Obstructive Uropathy1/131 (0.8%)
Renal Failure Acute2/131 (1.5%)
Urinary Retention4/131 (3.1%)
Urinary Tract Obstruction1/131 (0.8%)
Haematuria2/131 (1.5%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure1/131 (0.8%)
Pleural Effusion1/131 (0.8%)
Pneumonia Aspiration1/131 (0.8%)
Surgical and medical procedures
Nephrectomy1/131 (0.8%)
Transurethral Prostatectomy1/131 (0.8%)
Vascular disorders
Hypertension2/131 (1.5%)
Hypertensive Crisis1/131 (0.8%)
Hypotension1/131 (0.8%)
Embolism1/131 (0.8%)
Other (Not Including Serious) Adverse Events
Abiraterone Acetate
Affected / at Risk (%)# Events
Total118/131 (90.1%)
Blood and lymphatic system disorders
Anaemia9/131 (6.9%)
Gastrointestinal disorders
Constipation21/131 (16%)
Diarrhoea23/131 (17.6%)
Nausea25/131 (19.1%)
Vomiting20/131 (15.3%)
General disorders
Fatigue47/131 (35.9%)
Influenza Like Illness7/131 (5.3%)
Oedema Peripheral29/131 (22.1%)
Chest Pain7/131 (5.3%)
Infections and infestations
Nasopharyngitis15/131 (11.5%)
Sinusitis10/131 (7.6%)
Upper Respiratory Tract Infection21/131 (16%)
Urinary Tract Infection13/131 (9.9%)
Bronchitis7/131 (5.3%)
Injury, poisoning and procedural complications
Fall7/131 (5.3%)
Investigations
Alanine Aminotransferase Increased9/131 (6.9%)
Aspartate Aminotransferase Increased9/131 (6.9%)
Blood Creatine Phosphokinase Increased7/131 (5.3%)
Metabolism and nutrition disorders
Hyperglycaemia11/131 (8.4%)
Hypokalaemia42/131 (32.1%)
Musculoskeletal and connective tissue disorders
Arthralgia19/131 (14.5%)
Back Pain18/131 (13.7%)
Muscle Spasms10/131 (7.6%)
Musculoskeletal Pain10/131 (7.6%)
Pain in Extremity9/131 (6.9%)
Musculoskeletal Chest Pain9/131 (6.9%)
Myalgia7/131 (5.3%)
Nervous system disorders
Dizziness22/131 (16.8%)
Headache22/131 (16.8%)
Psychiatric disorders
Anxiety7/131 (5.3%)
Insomnia9/131 (6.9%)
Renal and urinary disorders
Haematuria15/131 (11.5%)
Micturition Urgency7/131 (5.3%)
Pollakiuria11/131 (8.4%)
Urinary Incontinence8/131 (6.1%)
Urinary Retention10/131 (7.6%)
Respiratory, thoracic and mediastinal disorders
Cough20/131 (15.3%)
Dyspnoea11/131 (8.4%)
Nasal Congestion9/131 (6.9%)
Skin and subcutaneous tissue disorders
Rash7/131 (5.3%)
Vascular disorders
Hot Flush13/131 (9.9%)
Hypertension53/131 (40.5%)

Limitations/Caveats

These results are up to clinical cutoff 31 December 2013 when all enrolled subjects either completed 6 cycles of treatment or withdrew from study prior to end of cycle 6. Primary endpoint results are complete.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.

Results Point of Contact

Name/TitleStrategic Lead Oncology Tas
OrganizationJanssen Services, LLC
Phone
EmailClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01314118
Other Study ID Numbers:
  • CR017932
  • Protocol 212082PCR2005
First Posted:
Mar 14, 2011
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021