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Acute Ischemic StrokePhase 3MACSINCT00893867

Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

A Phase 3 study testing DP-b99 in people with Acute Ischemic Stroke, run by D-Pharm Ltd. at 154 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
DP-b99
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
446 participants
Where
154 sitesin 18 countries
Study dates
Dec 2009to Apr 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • M or F age 18 - 85, inclusive
  • Suffered an acute, likely hemispheric, ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 3, 9 or 11):
  • Visual
  • Best Language
  • Extinction and Inattention (formerly Neglect)
  • Suffered the onset of an acute ischemic stroke that can be evaluated and treatment initiated within 9 hours after the onset of acute ischemic stroke symptoms.
Show all 10Show fewer
  • Screening NIHSS score of 10 to 16, inclusive
  • Readily accessible peripheral venous access for clinical trial material (CTM) administration and blood sampling
  • Ability to understand the requirements of the study and be willing to provide written informed consent as evidenced by signature on an informed consent document approved by an institutional review board or independent ethics committee, and agree to abide by the study restrictions and return for the required assessments.
  • Provided written authorization for use and disclosure of protected health information in accordance with the Health Insurance Portability and Accountability Act in the United States and the Personal Information Protection and Electronic Documents Act in Canada

Who cannot join

  • An intracerebral or subarachnoid hemorrhage per screening/baseline computerized tomography scan or susceptibility-weighted magnetic resonance imaging
  • A candidate for either:
  • thrombolytic therapy, or have been treated with thrombolytic therapy for the current stroke
  • mechanical thromboembolectomy, or have been treated with mechanical thromboembolectomy for the current stroke
  • Delirious, comatose or stuporous or demented, or having a mental impairment that in the investigator's opinion renders the subject incapable to participate in the study
  • Have seizure(s) anytime from stroke onset to screening/baseline NIHSS evaluation
Show all 23Show fewer
  • Neurological or non-neurological comorbidities that in the investigator's opinion may lead, independent of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may render the study's neurological assessments inconclusive for the purpose of evaluating solely the stroke's effects
  • Likely to undergo a procedure involving cardiopulmonary bypass during the study period
  • Suffered a myocardial infarction in the last 90 days
  • Any medical condition that in the investigator's opinion may threaten the subject's ability to complete the study (e.g., concurrent significant or life-threatening diseases, such as malignancies or end stage organ failure)
  • Rapid spontaneous improvement of neurological signs during screening/baseline assessments
  • Premorbid neurological deficits and functional limitations assessed by a pre-stroke Modified Rankin Scale score of > 1
  • Suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke
  • Either severe hypertension or hypotension, as measured by at least 2 consecutive supine measurements taken 10 minutes apart prior to randomization.
  • Significant current renal or hepatic disease(s): a serum creatinine concentration of >2.5 mg/dL; alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values that are three times greater than the upper limit of normal.
  • Have a platelet count of <100,000/mm3 or, for patients on oral anticoagulants at study entry, INR of >4
  • Female of childbearing potential who is not willing to use adequate and effective birth control measures for the duration of the trial. Effective birth control measures include hormonal contraception, a barrier method such as a diaphragm, intrauterine device and/or condom with spermicide
  • Positive urine pregnancy test at screening/baseline or be a lactating female
  • Currently dependent on, or abusing, alcohol or one or more of the following: sympathomimetic amines, cannabis, cocaine, hallucinogens, inhalants, opioids, phencyclidine, sedatives and hypnotics
  • Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication or have previously participated in a clinical trial involving DP-b99
  • Severe anemia as measured by a hemoglobin value of < 7 g/dl.
  • In a dependent relationship with the physician or the study sponsor.
  • Known hypersensitivity to any component of the investigational product.

Trial locations and contacts

154 sites in 18 countries.

154 sites in 18 countries

Germany27 sites

  • Ärztlicher Direktor Neurologische Klinik, Neurologische Klink GmbH der Rhoen-Klinikum AG

    Bad Neustadt / Saale

  • Marien-Krankenhaus gGmbH, Abteilung für Neurologie

    Bergisch Gladbach

  • DRK Kliniken Berlin, Klinik fuer Neurologie

    Berlin

  • Vivantes Klinikum Neukölln, Klinik für Neurologie, Stroke Unit

    Berlin

  • Klinikum Bremen-Mitte

    Bremen

  • Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

    Bremerhaven

  • Klinikum Chemnitz GmbH Chefarzt Klinik für Neurologie

    Chemnitz

  • Klinikum Köln Merheim, Department of Neurology

    Cologne

  • Helios Klinikum Erfurt GmbH

    Erfurt

  • Universitätsklinikum Erlangen, Neurologische klinik

    Erlangen

  • Universitätsklinikum Essen, Klinik und Poliklinik für Neurologie

    Essen

  • Neurologische Universitätsklinik Freiburg, Neurozentrum

    Freiburg im Breisgau, 79106

  • Klinikum Fulda, Neurologische Klinik

    Fulda

  • Evangelische Kliniken Gelsenkirchen GmbH Klinik für Neurologie und Klinische Neurophysiologie

    Gelsenkirchen

  • Georg-August-Universitat Gottingen Neurologische Klinik

    Göttingen

  • Ernst Moritz Arndt University

    Grifswald

  • Askepios Klinik Altona

    Hamburg

  • Askepios Klinik Heidberg

    Hamburg

  • Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Neurologie

    Leipzig

  • Klinikum der Otto-von-Guericke-Universität Magdeburg, Neurologische Universitätsklinik

    Magdeburg

  • Johannes Gutenberg Universitat, Klinik und Poliklinik fur Neurologie

    Mainz

  • Klinikum 1 Minden, Neurologische Klinik

    Minden

  • Universität Rostock Chefarzt Abteilung Neurologie

    Rostock

  • ASKLEPIOS Fachklinikum Teupitz

    Teupitz

  • Krankenhaus der Bramherzigen Brüder

    Trier

  • Universitätsklinikum Ulm, Abteilung für Neurologie im RKU

    Ulm

  • Heinrich Braun Klinikum Zwickau

    Zwickau

Other trials in Germany

United States13 sites

  • Tufts Medical Center

    Boston, Massachusetts

  • Presbitarian Hospital

    Charlotte, North Carolina

  • Associated Neurologists, P.C.

    Danbury, Connecticut

  • The Methodist Hospital

    Houston, Texas

  • The University of Kentucky The Methodist Hospital

    Lexington, Kentucky

  • University of Louisville, Kentucky Neuroscience Research

    Louisville, Kentucky

  • Research Center of Southern California

    Oceanside, California

  • Thomas Jefferson University

    Philadelphia, Pennsylvania

  • Carilion Clinic

    Roanoke, Virginia

  • Memorial Health University Medical Center

    Savannah, Georgia

  • Capital Health Regional Medical Center Neuroscience Institute

    Trenton, New Jersey

  • Legacy Meridian Park Medical Center

    Tualatin, Oregon

  • St. Elizabeth's Medical Center

    Youngstown, Ohio

Other trials in United States

Spain13 sites

  • Hospital Universitario de Albacete

    Albacete

  • Hospital De La Santa Ta Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Germans Triasy Pujol

    Barcelona

  • Hospital Vall D'hebron

    Barcelona

  • Hospital Gregorio Maranon

    Madrid

  • Hospital La Princesa

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario Clinico San Carlos

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela

  • Consorcio Hospital General Universitario Valencia

    Valencia

  • Hospital Clinico Universitario De Valladolid

    Valladolid

Other trials in Spain

Italy12 sites

  • Ospedale Regionale Valle d'Aosta

    Aosta

  • Dipartimento di Neuroscienze, Ospedale di Brotzu

    Cagliari

  • Ospedale di Circolo di Varese

    Lombardia

  • Istituto Scientifico San Raffaele - Stroke Unit

    Milan

  • Istituto Neurologico C. Mondino

    Pavia

  • Università di Perugia, Division of Internal and Cardiovascular Medicine - Stroke Unit

    Perugia

  • Presidio Ospedaliero di Piacenza

    Piacenza

  • Azienda Ospedaliera Sant'Andrea, Stroke Unit

    Rome

  • Istituto Patologia Generale U.C.S.C

    Rome

  • U.O.C. Stroke Unit

    Rome

  • Università di Roma "La Sapienza" - Stroke Unit

    Rome

  • Azienda Ospedaliera Universitaria "Santa Maria della Misericordia" Stroke Unit

    Udine

Other trials in Italy

Brazil9 sites

  • Santa Casa de Misericordia de Belo Horizonte Departamento de Neurologia

    Belo Horizonte

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre

  • Hospital Moinhos de Vento

    Porto Alegre

  • Hospital Mãe de Deus

    Porto Alegre

  • Santa Casa de Misericórdia de Porto Alegre Policlinica Santa Clara Sala de Neurologia

    Porto Alegre

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Unidade de Emergência Centro de Estudos

    Ribeirão Preto

  • Hospital São José de Joinville

    Santa Catarina

  • Hospital Santa Marcelina

    São Paulo

  • UNIFESP

    São Paulo

Other trials in Brazil

Hungary9 sites

  • Fővárosi Önkormányzat Péterfy Sándor utcai Kórház- Rendelőintézet és Baleseti Központ

    Budapest

  • Állami Egészségügyi Központ

    Budapest

  • Kenezy Korhaz Rendelointezet Egezsegugyi Szolgaltato Nonprofit Kft.

    Debrecen

  • University of Debrecen, Medical and Health Science Center

    Debrecen

  • Aladár Petz County Teaching Hospital

    Győr

  • PM Flór Ferenc County Hospital

    Kistarcsa

  • Borsod-Abaúj-Zemplén County Hospital Miskolc

    Miskolc

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs

  • Zala Megyei Kórház

    Zalaegerszeg

Other trials in Hungary

Poland9 sites

  • Pomerania Traumatology Center, Regional Specialist Hospital im. Nicolaus Copernicus

    Gdansk

  • Medical University of Lublin, Department of Neurology, Stroke Unit

    Lublin

  • Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Sandomierzu

    Sandomierz

  • Szpital Powiatowy im. Marii Curie - Skłodowskiej w Skarżysku-Kamiennej

    Skarżysko-Kamienna

  • Wojewodzki Szpital Specjalistyczny Nr 1 im. Prof. Jozefa Gasinskiego

    Tychy

  • Instytut Psychiatrii i Neurologii Oddział Neurologiczny z Pododdziałem Udarowym

    Warsaw

  • Medical University of Warsaw, Department of Neurology

    Warsaw

  • Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Neurologii

    Warsaw

  • Wojskowy Instytut Medyczny, Oddział Neurologii

    Warsaw

Other trials in Poland

South Korea9 sites

  • Dong-A Medical Center

    Busan

  • Inje University BUSAN Paik Hospital

    Busan

  • Inje University ILSAN Paik Hospital

    Goyang

  • Chonnam National University Hospital

    Gwangju

  • Inha University Hospital

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam

  • ASAN Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • The Catholic University of Korea Seoul St. Mary's hospital

    Seoul

Other trials in South Korea

Czechia8 sites

  • University Hospital Brno

    Brno

  • University Hospital Hradec Kralove, Clinic of Neurology

    Hradec Králové

  • Hospital Jihlava Clinic of Neurology

    Jihlava

  • Hospital Vítkovice Clinic of Neurology

    Ostrava

  • County Hospital Pardubice Clinic of Neurology

    Pardubice

  • Clinic of Neurology, Stroke Center, Charles University

    Prague

  • University Hospital Kralovske Vinohrady

    Prague

  • University Hospital Motol Clinic of Neurology

    Prague

Other trials in Czechia

Canada7 sites

  • Grey Nun's Community Hospital

    Edmonton

  • University of Alberta Hospital

    Edmonton

  • Hamilton Health Sciences Centre

    Hamilton, Ontario

  • Hamilton Health Sciences Centre

    Hamilton

  • Kingston General Hospital

    Kingston

  • Chinook Regional Hospital

    Lethbridge

  • CHA- Hôpital de l'Enfant-Jésus

    Québec

Other trials in Canada

France7 sites

  • CHU Jean Minjoz Besançon

    Besançon

  • Hopital Pellegrin-Tripode

    Bordeaux

  • CHU Henri Mondor

    Créteil

  • Hopital Gui de Chauliac

    Montpellier

  • Hôpital Bichat

    Paris

  • Hôpital Lariboisière - Service Neurologie

    Paris

  • Hôpital Saint Jean

    Perpignan

Other trials in France

South Africa6 sites

  • Fichmed

    Bloemfontein

  • Constantiaberg Medi-clinic

    Cape Town

  • Union Hospital

    Gauteng

  • Helderberg Research Institute

    Western Cape

  • Triervlei Trial Centre

    Western Cape

  • Clinical Projects Research

    Worcester

Other trials in South Africa

Israel5 sites

  • Bnai Zion Medical Center

    Haifa

  • Neurological Dept. Edith Wolfson Medical Center

    Holon, 58100

  • Meir Medical Center

    Kfar Saba

  • Sourasky Medical Center

    Tel Aviv

  • Chaim Sheba Medical Center

    Tel HaShomer

Other trials in Israel

Portugal5 sites

  • Hospital Professor Doutor Fernando Fonseca, EPE

    Amadora

  • Centro Hospitalar de Coimbra EPE

    Coimbra

  • Hospitais da Universidadde de Coimbra, EPE

    Coimbra

  • Centro de Estudos Egas Moniz - Hospital de Santa Maria

    Lisbon

  • Hospital de São Sebastião, EPE

    Santa Maria da Feira

Other trials in Portugal

Slovakia5 sites

  • Neurology Clinic, Faculty Hospital in Martin

    Martin

  • University Hospital Nitra

    Nitra

  • Hospital un Poliklinic

    Spišská Nová Ves

  • Faculty Hospital Trnava

    Trnava

  • Neurology dept.,Hospital Zilina

    Žilina

Other trials in Slovakia

Austria4 sites

  • Medizinische Universität Innsbruck

    Innsbruck

  • Landeskrankenhaus Klagenfurt

    Klagenfurt

  • Abt. Neurologie und Psychiatrie

    Linz

  • LKH St. Pölten Department of Neurology

    Sankt Pölten

Other trials in Austria

Netherlands4 sites

  • Catharina Ziekenhuis Neurologie

    Eindhoven

  • Medisch Spectrum Twente Hoofd Afdeling Vasculaire Neurologie

    Enschede

  • Atrium MC Parkstad

    Heerlen

  • Isala Klinieken Ploikliniek Neurologie

    Zwolle

Other trials in Netherlands

Switzerland2 sites

  • Universitätsspital Basel, Neurologie

    Basel

  • Universitätsspital Zürich, Klinik für Neurologie

    Zurich

Other trials in Switzerland

About this study

Official title: A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Phase 3 Pivotal Study to Assess the Safety and Efficacy of 1mg/kg/Day Intravenous DP-b99 Over 4 Consecutive Days Versus Placebo When Initiated Within Nine Hours of Acute Ischemic Stroke Onset

The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

Read the detailed description

This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national, parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with intravenous 1.0 mg/kg/d for 4 consecutive days, in acute ischemic stroke patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or Extinction and Inattention (formerly Neglect) (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11). An interim analysis for futility will be performed after Day 90 (or last available observation) primary endpoint data have been collected on about 45% of subjects planned to be enrolled. Clinical trial material (CTM) will be administered within 9 hours after the onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to receive either DP-b99 or placebo. A data and safety monitoring board (DSMB) will assess the accumulating safety data periodically and will oversee the interim futility analysis.

Being tested
DP-b99, Placebo
Keywords
acute ischemic stroke, neuroprotective agent
Medical subject headings
Ischemic Stroke

What participants receive

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

  • DP-b99Drug

    1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.

  • PlaceboDrug

    1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.

Study groups in NCT00893867
Study groupRoleWhat they receive
DP-b99ExperimentalNot described
Receives: Drug: DP-b99
MannitolPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Modified Rankin Scale (mRS) categorical analysis ("shift")

    Measured: 90 days

Secondary outcomes (4)

  1. Recovery, defined as a score of ≤ 1 on modified Rankin Score

    Measured: 90 days

  2. Safety and tolerability

    the numbers of patients with treatment-emergent adverse events, results of physical examination, 12-lead electrocardiogram, vital signs and laboratory tests (complete blood count, chemistry and urinalysis)

    Measured: throughout study - baseline until day 90

  3. recovery as assessed by an NIHSS of not more than 1

    Measured: 90 days

  4. 'home time'

    exploratory endpoint of 'home time', which measures the length of time (as number of nights)spent at home/relatives' home between hospital discharge and day 90

    Measured: 90 days

Timeline

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

  1. First posted6 May 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Why it stopped: The result of a pre-planned interim futility analysis

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00893867
Sponsor's protocol ID
Ptcl-01373
Acronym
MACSI
Status last verified
Oct 2012
First submitted
4 May 2009
Last updated
24 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Diener HC, Schneider D, Lampl Y, Bornstein NM, Kozak A, Rosenberg G. DP-b99, a membrane-activated metal ion chelator, as neuroprotective therapy in ischemic stroke. Stroke. 2008 Jun;39(6):1774-8. doi: 10.1161/STROKEAHA.107.506378. Epub 2008 Apr 10.

    PubMed 18403736

  • Rosenberg G, Angel I, Kozak A. Clinical pharmacology of DP-b99 in healthy volunteers: first administration to humans. Br J Clin Pharmacol. 2005 Jul;60(1):7-16. doi: 10.1111/j.1365-2125.2005.02378.x.

    PubMed 15963088

  • Barkalifa R, Hershfinkel M, Friedman JE, Kozak A, Sekler I. The lipophilic zinc chelator DP-b99 prevents zinc induced neuronal death. Eur J Pharmacol. 2009 Sep 15;618(1-3):15-21. doi: 10.1016/j.ejphar.2009.07.019. Epub 2009 Jul 19.

    PubMed 19622352

  • Rosenberg G, Bornstein N, Diener HC, Gorelick PB, Shuaib A, Lees K; MACSI investigators. The Membrane-Activated Chelator Stroke Intervention (MACSI) Trial of DP-b99 in acute ischemic stroke: a randomized, double-blind, placebo-controlled, multinational pivotal phase III study. Int J Stroke. 2011 Aug;6(4):362-7. doi: 10.1111/j.1747-4949.2011.00608.x. Epub 2011 Jun 6.

    PubMed 21645269

  • Rosenberg G, Marshall LS, Caraco Y. The neuroprotective agent DP-b99 does not interact with s-warfarin in vivo despite significant CYP2C9 inhibition in vitro. Basic Clin Pharmacol Toxicol. 2011 Apr;108(4):289-92. doi: 10.1111/j.1742-7843.2010.00654.x. Epub 2010 Dec 16. No abstract available.

    PubMed 21414144

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DP-b99 in people with Acute Ischemic Stroke, run by D-Pharm Ltd. at 154 sites in 18 countries.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 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: stopped early, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in Germany, United States, Spain, Italy, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

The study was stopped early (reason given: The result of a pre-planned interim futility analysis). Results are not available in the source record.

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?

Modified Rankin Scale (mRS) categorical analysis ("shift") (time frame: 90 days). 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 NCT00893867, which also lists 5 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 24 Oct 2012.

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