A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)

August 29, 2012 updated by: AstraZeneca

A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.

Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2577

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
      • Sydney, Australia
        • Research Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • Research Site
      • Hornsby, New South Wales, Australia
        • Research Site
      • Westmead, New South Wales, Australia
        • Research Site
      • Wollongong, New South Wales, Australia
        • Research Site
    • Victoria
      • Wodonga, Victoria, Australia
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Research Site
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • (Wilrijk) Antwerpen, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
    • Goias
      • Goiania, Goias, Brazil
        • Research Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Research Site
    • PR
      • Londrina, PR, Brazil
        • Research Site
    • Parana
      • Curitiba, Parana, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Research Site
    • Sao Paulo
      • Santo Andre, Sao Paulo, Brazil
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • Kitchener, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Oakville, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Greenfeild Park, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Point-Claire, Quebec, Canada
        • Research Site
      • Quebec City, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
      • La Serena, Chile
        • Research Site
      • Santiago, Chile
        • Research Site
      • Temuco, Chile
        • Research Site
      • Vina del Mar, Chile
        • Research Site
      • Beijing, China
        • Research Site
      • Chongqing, China
        • Research Site
      • Guangzhou City, China
        • Research Site
      • Hubei, China
        • Research Site
      • Jiangsu, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Shanxi, China
        • Research Site
      • Tianjin, China
        • Research Site
      • Zejiang, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site
      • Bogota, Colombia
        • Research Site
      • Medellin, Colombia
        • Research Site
      • Brno, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Jablonec nad Nisou, Czech Republic
        • Research Site
      • Kromeriz, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Prague 2, Czech Republic
        • Research Site
      • Prague 4, Czech Republic
        • Research Site
      • Prague 6, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Usti nad Labem, Czech Republic
        • Research Site
      • Aalborg, Denmark
        • Research Site
      • Frederiksberg, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
      • Holstebro, Denmark
        • Research Site
      • Kobenhavn, Denmark
        • Research Site
      • Odense, Denmark
        • Research Site
      • Roskilde, Denmark
        • Research Site
      • Helsinki, Finland
        • Research Site
      • Joensuu, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Seinajoki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Caen cedex, France
        • Research Site
      • Creteil, France
        • Research Site
      • Lille, France
        • Research Site
      • Lyon, France
        • Research Site
      • Lyon cedex 03, France
        • Research Site
      • Marseille, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Orleans Cedex, France
        • Research Site
      • Paris, France
        • Research Site
      • Pierre Benite cedex, France
        • Research Site
      • Poitiers Cedex, France
        • Research Site
      • Reims, France
        • Research Site
      • Reims cedex, France
        • Research Site
      • Rennes cedex 9, France
        • Research Site
      • Rouen, France
        • Research Site
      • Suresnes, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Vandoeuvre-les-Nancy cedex, France
        • Research Site
      • Villejuif, France
        • Research Site
      • Augsburg, Germany
        • Research Site
      • Bad Ems, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Borken, Germany
        • Research Site
      • Chemnitz, Germany
        • Research Site
      • Emmendingen, Germany
        • Research Site
      • Fuerth, Germany
        • Research Site
      • Gelsenkirchen-Buer, Germany
        • Research Site
      • Germering, Germany
        • Research Site
      • Goettingen, Germany
        • Research Site
      • Holzminden, Germany
        • Research Site
      • Kirchheim/Teck, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Muehlacker, Germany
        • Research Site
      • Muehlheim an der Ruhr, Germany
        • Research Site
      • Muenchen, Germany
        • Research Site
      • Muenchen-Planegg, Germany
        • Research Site
      • Muenster, Germany
        • Research Site
      • Reutlingen, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Tuebingen, Germany
        • Research Site
      • Waltshut-Tiengen, Germany
        • Research Site
      • Wuppertal, Germany
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
      • New Delhi, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
      • Nadiad, Gujarat, India
        • Research Site
    • Kerala
      • Kochi, Kerala, India
        • Research Site
    • Maharashtra
      • Pune, Maharashtra, India
        • Research Site
    • Tamil Nadu, India
      • Chennai, Tamil Nadu, India, India
        • Research Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • Research Site
    • West Bengal
      • Kolkota, West Bengal, India
        • Research Site
      • Dublin, Ireland
        • Research Site
      • Dublin 7, Ireland
        • Research Site
      • Dublin 8, Ireland
        • Research Site
      • Be'er Sheva, Israel
        • Research Site
      • Be'er-Ya'akov, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Holon, Israel
        • Research Site
      • Jeruslaem, Israel
        • Research Site
      • Petah-Tikva, Israel
        • Research Site
      • Tel-HaShomer - Ramat Gan, Israel
        • Research Site
      • Ancona, Italy
        • Research Site
      • Bari, Italy
        • Research Site
      • Bergamo, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Como, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Messina, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Rome, Italy
        • Research Site
      • Terni, Italy
        • Research Site
      • Varese, Italy
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
    • Aomori
      • Hirosaki-City, Aomori, Japan
        • Research Site
    • Chiba
      • Chiba-City, Chiba, Japan
        • Research Site
      • Narashino-city, Chiba, Japan
        • Research Site
    • Ehime
      • Matsuyama-City, Ehime, Japan
        • Research Site
    • Fukuoka
      • Fukuoka-City, Fukuoka, Japan
        • Research Site
    • Gunma
      • Maebashi-City, Gunma, Japan
        • Research Site
    • Hiroshima
      • Otake-City, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Sapporo-City, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Kobe-City, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Ibaraki-machi, Ibaraki, Japan
        • Research Site
      • Mito-City, Ibaraki, Japan
        • Research Site
      • Tsukuba-City, Ibaraki, Japan
        • Research Site
    • Kagawa
      • Kita-gun, Kagawa, Japan
        • Research Site
    • Kanagawa
      • Sagamihara-City, Kanagawa, Japan
        • Research Site
    • Kyoto
      • Kamigyo-ku, Kyoto, Japan
        • Research Site
      • Kyoto-City, Kyoto, Japan
        • Research Site
    • Miyagi
      • Sendai-City, Miyagi, Japan
        • Research Site
    • Nagano
      • Ueda-City, Nagano, Japan
        • Research Site
    • Nara
      • Kashihara, Nara, Japan
        • Research Site
    • Oita
      • Oita-City, Oita, Japan
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Research Site
    • Osaka
      • Osaka-City, Osaka, Japan
        • Research Site
      • Osaka-Sayama-City, Osaka, Japan
        • Research Site
      • Suita-City, Osaka, Japan
        • Research Site
    • Saitama
      • Wako-City, Saitama, Japan
        • Research Site
    • Shizuoka
      • Hamamatsu-city, Shizuoka, Japan
        • Research Site
      • Sunto-gun, Shizuoka, Japan
        • Research Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Research Site
      • Fuchu_city, Tokyo, Japan
        • Research Site
      • Itabashi-Ku, Tokyo, Japan
        • Research Site
      • Meguro-ku, Tokyo, Japan
        • Research Site
      • Minato-Ku, Tokyo, Japan
        • Research Site
      • Mitaka-City, Tokyo, Japan
        • Research Site
      • Shinjuku-ku, Tokyo, Japan
        • Research Site
    • Gyeonggi-do
      • Bundang-Gu, Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Research Site
    • Pusan
      • Seo-gu, Pusan, Korea, Republic of
        • Research Site
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of
        • Research Site
      • Seodaemun-gu, Seoul, Korea, Republic of
        • Research Site
      • Seongbuk-gu, Seoul, Korea, Republic of
        • Research Site
      • Songpa-gu, Seoul, Korea, Republic of
        • Research Site
      • Liepaja, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
    • Ciudad de Mexico
      • Distrito Federal, Ciudad de Mexico, Mexico
        • Research Site
    • Distrito Federal
      • Mexico DF, Distrito Federal, Mexico
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Arnhem, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Hertogenbosch, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
      • Tonsberg, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Arequipa, Peru
        • Research Site
      • Bellavista, Peru
        • Research Site
      • Jesus Maria, Peru
        • Research Site
      • Lima, Peru
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Kielce, Poland
        • Research Site
      • Koscierzyna, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj-Napoca, Romania
        • Research Site
    • Timis
      • Timisoara, Timis, Romania
        • Research Site
      • Barnaul, Russian Federation
        • Research Site
      • Kursk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Sochi, Russian Federation
        • Research Site
      • St.Petersburg, Russian Federation
        • Research Site
      • Voronezh, Russian Federation
        • Research Site
    • Omsk region
      • Omsk, Omsk region, Russian Federation
        • Research Site
    • Russia
      • Izhevsk, Russia, Russian Federation
        • Research Site
    • Tomsk Region
      • Tomsk, Tomsk Region, Russian Federation
        • Research Site
      • Belgrade, Serbia
        • Research Site
      • Nis, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
      • Pietermaritzburg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
    • Cape Town
      • Observatory, Cape Town, South Africa
        • Research Site
      • Tygerberg, Cape Town, South Africa
        • Research Site
    • Durban
      • Overport, Durban, South Africa
        • Research Site
    • Johannesburg
      • Parktown, Johannesburg, South Africa
        • Research Site
      • A Corunna, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
    • Alicante
      • Elche, Alicante, Spain
        • Research Site
    • Bizkaia
      • Barakaldo, Bizkaia, Spain
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Research Site
      • Gothenburg, Sweden
        • Research Site
      • Helsingborg, Sweden
        • Research Site
      • Jonkoping, Sweden
        • Research Site
      • Orebro, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Aarau, Switzerland
        • Research Site
      • CH-4031 Basel, Switzerland
        • Research Site
      • Locarno, Switzerland
        • Research Site
      • Zuerich, Switzerland
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Huddersfield, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle upon Tyne, United Kingdom
        • Research Site
    • Berkshire
      • Reading, Berkshire, United Kingdom
        • Research Site
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom
        • Research Site
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom
        • Research Site
    • Kent
      • Maidstone, Kent, United Kingdom
        • Research Site
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Greenbrae, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Connecticut
      • Norwich, Connecticut, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Port St. Lucie, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Macon, Georgia, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Rockville, Maryland, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • Research Site
    • Ohio
      • Canton, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Mystle Beach, South Carolina, United States
        • Research Site
      • Raleigh, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
      • Wenatchee, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Patients who answer TRUE to the following criteria may be eligible to participate in this study.

  • Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
  • Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
  • Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

Patients who answer TRUE to the following may NOT be eligible to participate in this study.

  • Currently using opiate based pain killers for cancer related pain
  • Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
  • Suffering from heart failure or had a myocardial infarction within last 6 months
  • A history of epilepsy or seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Matching Plcebo oral tablet once daily
Experimental: ZD4054
ZD4054 (Zibotentan)
10 mg once daily oral dose
Other Names:
  • Zibotentan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until date of death, assessed up to 33 months
Number of participants who have died at early analysis data cut off (DCO)
From date of randomization until date of death, assessed up to 33 months
Progression Free Survival
Time Frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Health Related Quality of Life
Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Prostate-specific Antigen (PSA) Progression
Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Symptomatic Progression
Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Kurt Miller, Prof., M.D., Charite University, Berlin, Germany
  • Principal Investigator: Tia Higano, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

April 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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