Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00638690
Registration number
NCT00638690
Ethics application status
Date submitted
13/03/2008
Date registered
19/03/2008
Date last updated
30/04/2014
Titles & IDs
Public title
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Query!
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Query!
Secondary ID [1]
0
0
COU-AA-301
Query!
Secondary ID [2]
0
0
CR016924
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone/prednisolone
Experimental: Abiraterone acetate plus prednisone/prednisolone -
Placebo comparator: Placebo plus prednisone/prednisolone -
Treatment: Drugs: Placebo
Four tablets once daily until disease progression
Treatment: Drugs: Abiraterone acetate
Four 250-mg tablets once daily until disease progression
Treatment: Drugs: Prednisone/prednisolone
5 mg twice daily until disease progression
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
Query!
Timepoint [1]
0
0
Up to 60 months
Query!
Secondary outcome [1]
0
0
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
Query!
Assessment method [1]
0
0
The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
Query!
Timepoint [1]
0
0
Up to 12 months
Query!
Secondary outcome [2]
0
0
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
Query!
Assessment method [2]
0
0
A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.
Query!
Timepoint [2]
0
0
Up to 12 months
Query!
Secondary outcome [3]
0
0
Radiographic Progression-free Survival
Query!
Assessment method [3]
0
0
Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion.
Query!
Timepoint [3]
0
0
Up to 11 months
Query!
Eligibility
Key inclusion criteria
* Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies
* At least one chemotherapy must have contained docetaxel
* Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
* Medical or surgical castration with testosterone < 50 ng/dL
* Adequate bone marrow, hepatic and renal function
* Potassium >= 3.5 mmol/L
* Able to swallow the study drug whole as a tablet
* Informed Consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* More than two prior cytotoxic chemotherapy regimens
* Prior Ketoconazole for prostate cancer
* Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
* Uncontrolled hypertension
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease
* Other malignancy
* Known brain metastasis
* GI disorder affecting absorption
* Not willing to use contraception
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1195
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Camperdown
Query!
Recruitment hospital [3]
0
0
- Footscray
Query!
Recruitment hospital [4]
0
0
- Geelong
Query!
Recruitment hospital [5]
0
0
- Heidelberg
Query!
Recruitment hospital [6]
0
0
- Herston
Query!
Recruitment hospital [7]
0
0
- Hobart
Query!
Recruitment hospital [8]
0
0
- Hornsby
Query!
Recruitment hospital [9]
0
0
- Kogarah
Query!
Recruitment hospital [10]
0
0
- Kurralta Park
Query!
Recruitment hospital [11]
0
0
- Liverpool
Query!
Recruitment hospital [12]
0
0
- Milton
Query!
Recruitment hospital [13]
0
0
- Parkville
Query!
Recruitment hospital [14]
0
0
- Perth
Query!
Recruitment hospital [15]
0
0
- Subiaco
Query!
Recruitment hospital [16]
0
0
- Wodonga
Query!
Recruitment hospital [17]
0
0
- Wollongong
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment postcode(s) [2]
0
0
- Camperdown
Query!
Recruitment postcode(s) [3]
0
0
- Footscray
Query!
Recruitment postcode(s) [4]
0
0
- Geelong
Query!
Recruitment postcode(s) [5]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [6]
0
0
- Herston
Query!
Recruitment postcode(s) [7]
0
0
- Hobart
Query!
Recruitment postcode(s) [8]
0
0
- Hornsby
Query!
Recruitment postcode(s) [9]
0
0
- Kogarah
Query!
Recruitment postcode(s) [10]
0
0
- Kurralta Park
Query!
Recruitment postcode(s) [11]
0
0
- Liverpool
Query!
Recruitment postcode(s) [12]
0
0
- Milton
Query!
Recruitment postcode(s) [13]
0
0
- Parkville
Query!
Recruitment postcode(s) [14]
0
0
- Perth
Query!
Recruitment postcode(s) [15]
0
0
- Subiaco
Query!
Recruitment postcode(s) [16]
0
0
- Wodonga
Query!
Recruitment postcode(s) [17]
0
0
- Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Hawaii
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Minnesota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Montana
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Nebraska
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nevada
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Linz
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Salzburg
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Wien
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Antwerpen
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Bonheiden
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Bruxelles
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Gent
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Hasselt
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Kortrijk
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Leuven
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Liege
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Roeselare
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Alberta
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
British Columbia
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Nova Scotia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Quebec
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Saskatchewan
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Calgary Ab
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
London
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Angers Cedex 01
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Caen
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Cannes
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Dijon
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Lyon
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Saint Herblain
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Vandoeuvre Les Nancy Cedex
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Villejuif N/A
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Aachen
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Berlin
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Dresden
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Hamburg
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Homburg/Saar
Query!
Country [65]
0
0
Hungary
Query!
State/province [65]
0
0
Pecs
Query!
Country [66]
0
0
Hungary
Query!
State/province [66]
0
0
Szombathely
Query!
Country [67]
0
0
Ireland
Query!
State/province [67]
0
0
Cork
Query!
Country [68]
0
0
Ireland
Query!
State/province [68]
0
0
Dublin 7
Query!
Country [69]
0
0
Ireland
Query!
State/province [69]
0
0
Dublin
Query!
Country [70]
0
0
Netherlands
Query!
State/province [70]
0
0
Nijmegen
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Badalona
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Barcelona
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Madrid
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
Belfast
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
Birmingham
Query!
Country [76]
0
0
United Kingdom
Query!
State/province [76]
0
0
Cambridge
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Glasgow
Query!
Country [78]
0
0
United Kingdom
Query!
State/province [78]
0
0
London
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
Manchester
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Newcastle Upon Tyne
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Northwood
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
Oxford
Query!
Country [83]
0
0
United Kingdom
Query!
State/province [83]
0
0
Sutton
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Whitchurch
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Cougar Biotechnology, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00638690
Query!
Trial related presentations / publications
Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22. Chi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18. Fizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25. Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13. Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31. Scher HI, Heller G, Molina A, Attard G, Danila DC, Jia X, Peng W, Sandhu SK, Olmos D, Riisnaes R, McCormack R, Burzykowski T, Kheoh T, Fleisher M, Buyse M, de Bono JS. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer. J Clin Oncol. 2015 Apr 20;33(12):1348-55. doi: 10.1200/JCO.2014.55.3487. Epub 2015 Mar 23. Mulders PF, Molina A, Marberger M, Saad F, Higano CS, Chi KN, Li J, Kheoh T, Haqq CM, Fizazi K. Efficacy and safety of abiraterone acetate in an elderly patient subgroup (aged 75 and older) with metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. Eur Urol. 2014 May;65(5):875-83. doi: 10.1016/j.eururo.2013.09.005. Epub 2013 Sep 20. Harland S, Staffurth J, Molina A, Hao Y, Gagnon DD, Sternberg CN, Cella D, Fizazi K, Logothetis CJ, Kheoh T, Haqq CM, de Bono JS, Scher HI; COU-AA-301 Investigators. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer. 2013 Nov;49(17):3648-57. doi: 10.1016/j.ejca.2013.07.144. Epub 2013 Aug 22. Ryan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, Grant RP, de Bono JS, Scher HI. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol. 2013 Aug 1;31(22):2791-8. doi: 10.1200/JCO.2012.45.4595. Epub 2013 Jul 1. Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. doi: 10.1016/S1470-2045(12)70473-4. Epub 2012 Nov 9. Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18. Erratum In: Lancet Oncol. 2012 Nov;13(11):e464. Lancet Oncol. 2014 Aug;15(9):e365. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Cougar Biotechnology, Inc Clinical Trial
Query!
Address
0
0
Cougar Biotechnology, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00638690
Download to PDF