Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

December 17, 2020 updated by: Novartis Pharmaceuticals
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1988

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • 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

  • Argentina
      • Buenos Aires, Argentina, B1642DCD
        • Grupo Medico Alem
      • Buenos Aires, Argentina, B1704ETD
        • DIM Clinical Privada
      • Buenos Aires, Argentina, B1824KAJ
        • Clinica Medica Sin Internacion
      • Buenos Aires,, Argentina, C1027AAP
        • Fundación de Estudios Farmacológicos y de Medicamentos
    • Santa Fe
      • Buenos Aires, Santa Fe, Argentina, 3000FNF
        • Instituto de Investigaciones Biomedicas
      • Rosario, Santa Fe, Argentina, S2002OJP
        • Grupo Colaborative Rosario
  • Austria
      • Graz, Austria, 8036
        • Universitaetsklinik Graz medizinische Universitaetsklinik;
      • Salzburg, Austria, 5020
        • LKH Salzburg Landesklinik fuer Innere Medizin I
      • Wien, Austria, 1060
        • Millergasse 7
      • Wien, Austria, 1140
        • Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
      • Wiener Neustadt, Austria, 2700
        • Kindlergasse 4
      • Wiener Neustadt, Austria
        • Kindlergasse 4
  • Belgium
      • De Pinte, Belgium, 9840
        • Private Practice Cardiology (Dr. Hollanders)
      • Genk, Belgium, 3600
        • Private Practice (Vernijns)
      • Gozee, Belgium, 6534
        • Private Practice (Dr. De Meulemeester)
      • Hasselt, Belgium, 3500
        • Huisartsenpraktijk Hygeia
      • Oostham, Belgium, 3945
        • Private Practice (Dr. Jaak Mortelmans)
    • Sint-Niklaasstraat 117
      • Sint-Gillis-Waas, Sint-Niklaasstraat 117, Belgium, 9170
        • Private Practice Diabetology (Dr. Coucke)
  • Finland
      • Helsinki, Finland, 2 A 2 00270
        • Lihavuustutkimusyksikkö
      • Helsinki, Finland, 47 A 00260
        • Mehiläinen Töölö Diabetesklinikka
      • Kuopio, Finland, 70100
        • Terveystalo Kuopio
      • Lahti, Finland, 6 C 15110
        • Mehiläinen Lahti
      • Oulu, Finland, 90100
        • ODL Terveys Oy, Tutkimusyksikkö,
      • Riihimäki, Finland, 11130
        • Mehiläinen Riihimäki
      • Tampere, Finland, 33900
        • Terveystalo Tampereen työterveys Kalmar
      • Vantaa, Finland, 01600
        • Myyrmäen terveysasema
  • Germany
      • Augsburg, Germany, 86150
        • Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
      • Augsburg, Germany, 86150
        • Praxis Dr. Med. Kurt Rack
      • Bad Kreuznach, Germany, 55545
        • Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
      • Berlin, Germany, 10117
        • Klinische Forschung Berlin-Buch
      • Berlin, Germany, 12247
        • Praxis Dr. Med. Ulrike Venschott-Jordan
      • Berlin, Germany, 12347
        • Praxis Dr. Med. Monika Kiper
      • Berlin, Germany, 13189
        • Praxis Dr. Med. Christina Bondke
      • Bibertal, Germany, 89346
        • Bibertal Klinik
      • Diez, Germany, 65582
        • Gemeinschaftspraxis Dr. med. Ali Boustani
      • Dorsten, Germany, 46282
        • Facharzt fuer Allgemeinmedizin
      • Einbeck, Germany, 37574
        • Praxis Dr. Med. Anwar Ansari
      • Essen, Germany, 45130
        • Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin
      • Essen, Germany, 45144
        • Praxis Dr. Med. Roland Kutzke
      • Essen, Germany, 45276
        • Praxis Dr. Med. Thorsten Rau
      • Falkensee, Germany, 14612
        • Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie
      • Frankfurt, Germany, 60599
        • Praxis Dr. Med. Daniela Freise
      • Freital, Germany, 01705
        • Dial.-Med. Kerstin Steinbach
      • Fulda, Germany, 36037
        • Gemeinschaftspraxis
      • Grimma, Germany, 04668
        • Praxis Dr. Med. Wolfgang Krause
      • Hagenow, Germany, 19230
        • Krankenhaus Hagenow, Innere Medizin
      • Hamburg, Germany, 20097
        • MVZ-medicum Hamburg
      • Hamburg, Germany, 22041
        • Diabetes-Zentrum Wandsbek
      • Herne, Germany, 44653
        • Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
      • Hildesheim, Germany, 31139
        • Praxis Dr. Med. Helmut Anderten
      • Kahla, Germany, 07768
        • Praxis Dr. Med. Juergen Landschulze
      • Karlsruhe, Germany, 76199
        • Praxis Dr. Med. Julia Chevts
      • Kassel, Germany, 34125
        • Praxis Dr. Med. Hans-Helmut Seibert
      • Koeln, Germany, 50823
        • Praxis Dr. Med. Claudia Ulbrich
      • Kuenzing, Germany, 94550
        • Dres. Klein/Minnich
      • Leipzig, Germany
        • Praxis Dr. Med. Birgit Hoene
      • Luebeck, Germany, 23562
        • Pro Scientia med
      • Meissen, Germany, 01662
        • Diabetes Schwerpunktpraxis
      • Muehldorf, Germany, 84453
        • Praxis Dres. Prohaska / Lindner
      • Muenchen, Germany, 81373
        • Praxis Dr. Med. Claus-Michael Grimm
      • Muenster, Germany, 48153
        • Praxis Dr. Fischer & Dr. Keuthage
      • Neumunster, Germany, 24534
        • Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
      • Oberhausen, Germany, 46049
        • Praxis Dr. Med. Joachim Etter
      • Potsdam, Germany, 14469
        • IkFE Studiencenter Potsdam GMBH i.G.
      • Quakenbrueck, Germany, 49610
        • Diabetes Center Quakenbrueck
      • Reinfeld, Germany, 23858
        • Praxis Dr. Altwicker, Dr. Kanis
      • Rothenburg, Germany
        • Praxis Dr. Med. Ulrich Aigner
      • Schoenberg, Germany, 23923
        • Praxis Dr. Med. Sabine Sedl
      • Schrobenhausen, Germany, 86529
        • Dres. Hiltensperger & Schaal
      • Schwabenheim, Germany, 55270
        • Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
      • Stuttgart, Germany, 70469
        • Praxis Dr. Med. Ottmar Herfert
      • Veitsbronn, Germany, 90587
        • Praxis Dr. Med. Doru Popa
      • Viernheim, Germany, 68519
        • Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer
      • Wangen, Germany, 88239
        • Gemeinschaftspraxis Sauter
      • Weissenhorn, Germany, 89264
        • Praxis Dr. Med. Rudolf Matthias Remppis
      • Welzheim, Germany, 73642
        • Praxis Dr. Med. Peter Genthner
      • Wetzlar, Germany, 35584
        • Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider
  • Greece
      • Athens, Greece, GR11527
        • Laiko General Hospital,
      • Larisa, Greece, GR 35100
        • Lamia General Hospital
      • Thessaloniki, Greece, GR56403
        • Papageorgiou General Hospital
  • Guatemala
      • Guatemala City, Guatemala, 01001
        • Clínica y Hospital Colón del Paciente Diabético
      • Guatemala City, Guatemala, 01010
        • Endonutri S.A
      • Guatemala City, Guatemala, 11-49
        • Clínica y Hospital Colón del Paciente Diabético
      • Guatemala City, Guatemala, Oficina 1114
        • Clinica Dr. Erick Turcios
      • Guatemala City, Guatemala, Oficina 909
        • Endonutri S. A.
      • Guatemala City, Guatemala
        • Clinica Dr. Sergio Bran
  • Hungary
      • Budapest, Hungary, 1032
        • Szent Margit Hospita
      • Budapest, Hungary, 1041
        • Károlyi Sándor Hospital
      • Budapest, Hungary, 1115
        • Szent Imre Hospital
      • Csongrád, Hungary, 6640
        • Konszenzusplusz Kft.
      • Győr, Hungary, 9023
        • Petz Aladar Hospital
      • Nyíregyháza, Hungary
        • Josa Andras Hospital
      • Szeged, Hungary, 6720
        • Szte-Áok I
      • Szekszárd, Hungary, 7100
        • Balassa Janos Hospital
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Hospital
  • India
      • Chennai, India, 13
        • M. V. Hosp for Diabetes P. Ltd. 4,
      • Hyderabaad, India, 500 036
        • Medicity Hospital
      • Hyderabaad, India, 500 082
        • Nizam's Institute of Medical Sciences,
      • Jaipur, India, 302001
        • S. R. Kalla Memorial gastro and general hosp,
      • Vellore, India, P. O. Box. No. 3.
        • Christian Medical College,
    • Karantaka
      • Bangalore, Karantaka, India, 560 017
        • Manipal Hospital,
    • Kerela
      • Trivandrum, Kerela, India, 695 001
        • Health and Research Centre
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452001
        • Diabetes Thyroid Hormone Research Institute Pvt Ltd.
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 500 082
        • Madras Diabetes Research Foundation
  • Israel
      • Rishon Le Zion, Israel, 75650
        • Maccabi Healthcare Services
      • Safed, Israel, 13100
        • Ziv Medical Center
  • Italy
      • Arenzano, Italy
        • U.O.C. di Diabetologia e Malattie Metaboliche
      • Bergamo, Italy
        • U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina
      • Campobasso, Italy
        • U.O.C. Diabetologia Endocrinologia Dip. Medico
      • Casorate Primo, Italy
        • U.O. Medicina Generale
      • Catania, Italy
        • I Divisione Medicina
      • Chieri, Italy
        • U.O. Malattie Metaboliche e Diabetologia
      • Cosenza, Italy
        • U.O.C. di Medicina d'Urgenza e Pronto Soccorso
      • Firenze, Italy
        • Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi
      • Mercato San Severino, Italy
        • Centro Diabetologico Malattie Metaboliche
      • Milano, Italy
        • Divisione Malattie Metaboliche e Diabetologia
      • Milano, Italy
        • S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna
      • Milano, Italy
        • U.O. Medicina II - Dip. Medicina Interna
      • Milano, Italy
        • Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna
      • Olbia, Italy
        • U.O. Diabetologia
      • Roma, Italy
        • Centro per l'Aterosclerosi Dip. di Medicina Interna
      • Roma, Italy
        • U.O. Endocrinologia e Diabetologia
      • Roma, Italy
        • U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale
      • Roma, Italy
        • U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica
      • Siena, Italy
        • S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche
      • Vibo Valentia, Italy
        • S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Eulji General Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea Holy Family Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
  • Latvia
      • Daugavpils, Latvia, 5417
        • Daugavpils Regional Hospital
      • Liepaja, Latvia, 3401
        • Primary Health Centre of Jaunliepaja
      • Ogre, Latvia, 5001
        • Private practice of endocrinology
      • Riga, Latvia, 1002
        • Center of Endocrinology
      • Riga, Latvia, 1057
        • Riga Outpatient Clinic "Dziednieciba"
      • Talsi, Latvia, 3201
        • Talsi Clinical Hospital
      • Valmiera, Latvia, 4201
        • Endocrinology Department of Vidzemes Hospital
  • Lithuania
      • Alytus, Lithuania, 63257
        • JSC "Klinikiniai sprendimai"
      • Kaunas, Lithuania, 50009
        • Kaunas Medical University Hospital
      • Kaunas, Lithuania, 45130
        • Kaunas District Hospital
      • Kaunas, Lithuania, 48259
        • Kaunas Silainiai Outpatient Clinic
      • Kaunas, Lithuania, 51270
        • Kaunas Dainavos Outpatient Clinic
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santariskiu Clinics
      • Vilnius, Lithuania, 09112
        • Private Endocrinology Clinic
  • Mexico
      • Durango, Mexico, 34070
        • Clínica de Diabetes de la Secretaria de Salud de Durango
      • Mexico City, Mexico, 06700
        • ARKE Estudios Clínicos S.A. de C.V.
    • Durango
      • Mexico City, Durango, Mexico, 03300
        • Comité Bioetico para la Investigación Clínica S.C.
    • Morelos.
      • Cuernavaca, Morelos., Mexico
        • Unidad Metabolica y Cardiovascular S.C.
    • Polanco Chapultepec
      • Mexico City, Polanco Chapultepec, Mexico, 11550
        • Clínica Eugenio Sue
  • Norway
      • Hønefoss, Norway, 3503
        • Flattum legesenter
      • Kristiansand, Norway
        • Randesund Helsesenter
      • Oslo, Norway
        • Oslo Universitetssykehus
      • Oslo, Norway, 0580
        • Sinsenklinikken
      • Stavanger, Norway, 4020
        • Hinnastrekanten legekontor
      • Vennesla, Norway
        • Vennesla legesenter
  • Peru
      • Arequipa, Peru
        • Clinica San Miguel
      • LIma, Peru
        • Clinica San Borja
      • Lima, Peru
        • Hospital Nacional Guillermo Almenara Irigoyen
      • Lima, Peru
        • Hospital Nacional Cayetano Heredia
      • Lima, Peru
        • Clinica Geriatrica Militar
      • Lima, Peru
        • Clinica Senor de los Milagros
  • Poland
      • Bydgoszcz, Poland, 85 822
        • Bydgoskie Centrum Diabetologii i Endokrynologii
      • Kutno, Poland, 99 300
        • NZOZ "Specjalista" Sp z o. o.
      • Mielec, Poland, 39 300
        • Oddzial Chorob Wewnetrznych
      • Poznan, Poland, 60 521
        • Poradnia Lekarza Rodzinnego
      • Poznań, Poland, 60 773
        • Poznański Ośrodek Medyczny "NOVAMED"
  • Romania
      • Baia Mare, Romania, ap. 72
        • CMI Cardiologie "Dr. Pop Calin Florin"
      • Bucharest, Romania, district 1
        • "C. I. Parhon" Endocrinology Institute
      • Bucharest, Romania, district 2
        • Medical Centre "Sanatatea Ta" SRL
      • Oradea, Romania, ap. 3
        • Medical Practice SRL
      • Oradea, Romania, ap. 5
        • Anamed SRL
      • Ploiesti, Romania, no. 100
        • Emergency County Hospital Ploiesti
      • Timisoara, Romania, no. 27
        • Policlinica "Dr. Citu"
  • Slovakia
      • Bratislava, Slovakia, 821 07
        • Diametabol.s.r.o.,
      • Povazska Bystrica, Slovakia, 017 01
        • MUDr. Margita Kiripolska s.r.o
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 811 02
        • MEDISPEKTRUM s.r.o,
      • Presov, Slovak Republic, Slovakia, 081 81
        • .Interna klinika, FN J.A. Reimana
    • Slovakia Republic
      • Bratislava, Slovakia Republic, Slovakia, 81272
        • Diabetologicka ambulancia,
      • Kosice, Slovakia Republic, Slovakia, 040 01
        • Diabetologicka ambulancia
      • Lucenec, Slovakia Republic, Slovakia, 984 01
        • Diabetologicka ambulancia,
      • Nove Zamky, Slovakia Republic, Slovakia, 940 01
        • NZZ Diabetologicka ambulancia
      • Trencin, Slovakia Republic, Slovakia, 911 01
        • Diabetes Centrum s.r.o
      • Zilina, Slovakia Republic, Slovakia, 010 01
        • Diabetologicka ambulancia,
  • Venezuela
      • Caracas, Venezuela
        • Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.
      • Caracas., Venezuela, Piso 4. Urb.
        • Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.
    • Carabobo.
      • Valencia, Carabobo., Venezuela
        • Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18-78 years old inclusive at Visit 1
  • T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
  • Patient agreement to maintain same dose of metformin throughout study
  • HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
  • Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Drug: Metformin
ACTIVE_COMPARATOR: Sitagliptin
Drug: Metformin
Drug: Sitagliptin
EXPERIMENTAL: Vildagliptin Dose 1
Drug: Metformin
Drug: Vildagliptin
EXPERIMENTAL: Vildagliptin Dose 2
Drug: Metformin
Drug: Vildagliptin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment.
Time Frame: 24 weeks
24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment.
Time Frame: 24 weeks
24 weeks
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin.
Time Frame: 24 weeks
24 weeks
To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.
Time Frame: 24 weeks
24 weeks
To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.
Time Frame: 76 weeks
76 weeks
To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.
Time Frame: 24 weeks
24 weeks
To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.
Time Frame: 76 weeks
76 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLAF237B2224

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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