An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
3 other identifiers
interventional
776
16 countries
201
Brief Summary
Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. Secondary Objective: To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:
- Safety and tolerability
- Dupilumab systemic exposure and anti-drug antibodies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jun 2013
Typical duration for phase_2 asthma
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 2, 2017
CompletedJune 26, 2017
June 1, 2017
1.4 years
May 10, 2013
April 27, 2017
June 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Absolute Change From Baseline in FEV1 at Week 12: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Secondary Outcomes (20)
Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population
Baseline, Week 12
Percent Change From Baseline in FEV1 at Week 12: ITT Population
Baseline, Week 12
Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population
Baseline to Week 24
Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population
Baseline to Week 24
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
Baseline up to Week 24
- +15 more secondary outcomes
Study Arms (5)
Dupilumab 300 mg q2w
EXPERIMENTAL2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Dupilumab 200 mg q2w
EXPERIMENTAL2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Dupilumab 300 mg q4w
EXPERIMENTAL2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Dupilumab 200 mg q4w
EXPERIMENTAL2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Placebo q2w
PLACEBO COMPARATOR2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Interventions
Solution for injection, Subcutaneous injection
Solution for injection, Subcutaneous injection
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Oral inhalation as needed
Oral inhalation as needed
Eligibility Criteria
You may qualify if:
- Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for \>=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:
- Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist
- Forced expiratory volume (FEV1) 40 to 80% of predicted normal
- Asthma Control Questionnaire, 5-question version (ACQ-5) score \>=1.5
- Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
- Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma
You may not qualify if:
- Participants \<18 years
- Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests
- Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma
- Current smoker or cessation of smoking within 6 months prior to Visit 1
- Previous smoker with a smoking history \>10 pack-years
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (201)
Investigational Site Number 840050
Fullerton, California, 92835, United States
Investigational Site Number 840041
Huntington Beach, California, 92647, United States
Investigational Site Number 840019
Los Angeles, California, 90025, United States
Investigational Site Number 840029
Los Angeles, California, 90025, United States
Investigational Site Number 840022
Los Angeles, California, 90048, United States
Investigational Site Number 840013
Mission Viejo, California, 92691, United States
Investigational Site Number 840044
Newport Beach, California, 92663, United States
Investigational Site Number 840007
Riverside, California, 92506, United States
Investigational Site Number 840014
Rolling Hills Estates, California, 90274, United States
Investigational Site Number 840036
San Jose, California, 95117, United States
Investigational Site Number 840032
Colorado Springs, Colorado, 80907, United States
Investigational Site Number 840040
Colorado Springs, Colorado, 80907, United States
Investigational Site Number 840043
Denver, Colorado, 80206, United States
Investigational Site Number 840006
Denver, Colorado, 80230, United States
Investigational Site Number 840024
Denver, Colorado, 80230, United States
Investigational Site Number 840027
Daytona Beach, Florida, 32117, United States
Investigational Site Number 840039
Miami, Florida, 33135, United States
Investigational Site Number 840048
Albany, Georgia, 31707, United States
Investigational Site Number 840026
River Forest, Illinois, 60305, United States
Investigational Site Number 840053
Evansville, Indiana, 47713, United States
Investigational Site Number 840017
Louisville, Kentucky, 40223-5440, United States
Investigational Site Number 840030
Owensboro, Kentucky, 42303, United States
Investigational Site Number 840028
Baltimore, Maryland, 21287, United States
Investigational Site Number 840052
Wheaton, Maryland, 20902, United States
Investigational Site Number 840045
North Dartmouth, Massachusetts, 02747, United States
Investigational Site Number 840046
Novi, Michigan, 48375, United States
Investigational Site Number 840051
Novi, Michigan, 48375, United States
Investigational Site Number 840018
Minneapolis, Minnesota, 55402, United States
Investigational Site Number 840002
St Louis, Missouri, 63110, United States
Investigational Site Number 840003
St Louis, Missouri, 63141, United States
Investigational Site Number 840037
Missoula, Montana, 59804, United States
Investigational Site Number 840004
Papillion, Nebraska, 27103, United States
Investigational Site Number 840011
Princeton, New Jersey, 08540, United States
Investigational Site Number 840016
Rochester, New York, 14618, United States
Investigational Site Number 840025
Cincinnati, Ohio, 45231, United States
Investigational Site Number 840015
Cincinnati, Ohio, 45236, United States
Investigational Site Number 840020
Cincinnati, Ohio, 45241, United States
Investigational Site Number 840001
Oklahoma City, Oklahoma, 73120, United States
Investigational Site Number 840031
Lake Oswego, Oregon, 97035, United States
Investigational Site Number 840034
Medford, Oregon, 97504, United States
Investigational Site Number 840042
Philadelphia, Pennsylvania, 19107, United States
Investigational Site Number 840010
Pittsburgh, Pennsylvania, 15213, United States
Investigational Site Number 840009
Upland, Pennsylvania, 19013, United States
Investigational Site Number 840021
Spartanburg, South Carolina, 29303, United States
Investigational Site Number 840023
Dallas, Texas, 75231, United States
Investigational Site Number 840005
El Paso, Texas, 79902, United States
Investigational Site Number 840008
San Antonio, Texas, 78229, United States
Investigational Site Number 840035
Richmond, Virginia, 23225, United States
Investigational Site Number 840054
Everett, Washington, 98203, United States
Investigational Site Number 840033
Tacoma, Washington, 98405, United States
Investigational Site Number 032004
Buenos Aires, B6500BWQ, Argentina
Investigational Site Number 032003
Buenos Aires, C1121ABE, Argentina
Investigational Site Number 032008
Caba, 1424, Argentina
Investigational Site Number 032010
Caba, 1425, Argentina
Investigational Site Number 032001
Caba, Argentina
Investigational Site Number 032002
La Plata, 1900, Argentina
Investigational Site Number 032005
Rosario, 2000, Argentina
Investigational Site Number 032006
Rosario, 2000, Argentina
Investigational Site Number 032007
Rosario, 2000, Argentina
Investigational Site Number 032009
San Miguel de Tucumán, 4000, Argentina
Investigational Site Number 032012
Santa Fe, 3000, Argentina
Investigational Site Number 036004
Adelaide, 5000, Australia
Investigational Site Number 036002
Brisbane, 4101, Australia
Investigational Site Number 036005
Campbelltown, 2560, Australia
Investigational Site Number 036001
Clayton, 3168, Australia
Investigational Site Number 036008
Frankston, 3199, Australia
Investigational Site Number 036003
Nedlands, 6009, Australia
Investigational Site Number 036009
Prahran, 3004, Australia
Investigational Site Number 036006
Woolloongabba, 4102, Australia
Investigational Site Number 152007
Quillota, 226000, Chile
Investigational Site Number 152011
Santiago, 00000, Chile
Investigational Site Number 152001
Santiago, 7500710, Chile
Investigational Site Number 152002
Santiago, 8380456, Chile
Investigational Site Number 152014
Santiago, 8910131, Chile
Investigational Site Number 152003
Santiago, Chile
Investigational Site Number 152005
Santiago, Chile
Investigational Site Number 152012
Santiago, Chile
Investigational Site Number 152013
Santiago, Chile
Investigational Site Number 152008
Talca, Chile
Investigational Site Number 152006
Viña del Mar, Chile
Investigational Site Number 250009
Brest, 29610, France
Investigational Site Number 250004
Grenoble, 38043, France
Investigational Site Number 250010
Lille, 59037, France
Investigational Site Number 250006
Lyon, 69317, France
Investigational Site Number 250001
Marseille, 13915, France
Investigational Site Number 250002
Montpellier, 34295, France
Investigational Site Number 250005
Nantes, 44093, France
Investigational Site Number 250007
Nîmes, 30029, France
Investigational Site Number 250003
Pessac, 33604, France
Investigational Site Number 250008
Strasbourg, 67091, France
Investigational Site Number 250011
Vernon, 27200, France
Investigational Site Number 380010
Ancona, 60126, Italy
Investigational Site Number 380009
Catania, 95123, Italy
Investigational Site Number 380004
Ferrara, 44121, Italy
Investigational Site Number 380002
Florence, 50134, Italy
Investigational Site Number 380008
Foggia, 71100, Italy
Investigational Site Number 380003
Modena, 41124, Italy
Investigational Site Number 380007
Padua, 35128, Italy
Investigational Site Number 380001
Pisa, 56100, Italy
Investigational Site Number 380005
Torino, 10126, Italy
Investigational Site Number 380006
Verona, 37126, Italy
Investigational Site Number 392009
Asahi-Shi, Japan
Investigational Site Number 392037
Chiyoda-Ku, Japan
Investigational Site Number 392007
Chuoh-Ku, Japan
Investigational Site Number 392002
Chūōku, Japan
Investigational Site Number 392012
Edogawa-Ku, Japan
Investigational Site Number 392017
Fukuoka, Japan
Investigational Site Number 392021
Fukuyama-Shi, Japan
Investigational Site Number 392030
Habikino-Shi, Japan
Investigational Site Number 392004
Himeji-Shi, Japan
Investigational Site Number 392032
Hirakata-Shi, Japan
Investigational Site Number 392013
Iizuka-Shi, Japan
Investigational Site Number 392042
Isesaki-Shi, Japan
Investigational Site Number 392026
Itabashi-Ku, Japan
Investigational Site Number 392023
Kanazawa, Japan
Investigational Site Number 392001
Kitakyushu-Shi, Japan
Investigational Site Number 392022
Kiyose-Shi, Japan
Investigational Site Number 392025
Kobe, Japan
Investigational Site Number 392040
Kodaira-Shi, Japan
Investigational Site Number 392044
Kokubunji-Shi, Japan
Investigational Site Number 392010
Kurashiki-Shi, Japan
Investigational Site Number 392036
Kyoto, Japan
Investigational Site Number 392041
Nagaoka-Shi, Japan
Investigational Site Number 392020
Naka-Gun, Japan
Investigational Site Number 392015
Nakano, Japan
Investigational Site Number 392005
Naruto-Shi, Japan
Investigational Site Number 392043
Ohta-Shi, Japan
Investigational Site Number 392019
Sagamihara-Shi, Japan
Investigational Site Number 392011
Sakaide-Shi, Japan
Investigational Site Number 392024
Sakaishi, Japan
Investigational Site Number 392008
Sapporo, Japan
Investigational Site Number 392034
Sapporo, Japan
Investigational Site Number 392038
Setagaya-Ku, Japan
Investigational Site Number 392028
Sumida-Ku, Japan
Investigational Site Number 392006
Tomakomai-Shi, Japan
Investigational Site Number 392003
Toride-Shi, Japan
Investigational Site Number 392029
Tsu, Japan
Investigational Site Number 392018
Tsukubo-Gun, Japan
Investigational Site Number 392045
Uruma, Japan
Investigational Site Number 392014
Yokohama, Japan
Investigational Site Number 392035
Yokohama, Japan
Investigational Site Number 484006
Chihuahua City, 31000, Mexico
Investigational Site Number 484005
Distrito Federal, 07760, Mexico
Investigational Site Number 484001
Guadalajara, 44100, Mexico
Investigational Site Number 484004
Mexico City, 64718, Mexico
Investigational Site Number 484003
Monterrey, 64460, Mexico
Investigational Site Number 554001
Dunedin, 9012, New Zealand
Investigational Site Number 554002
Wellington, 6021, New Zealand
Investigational Site Number 616006
Bialystok, 15-025, Poland
Investigational Site Number 616004
Gdansk, 80-405, Poland
Investigational Site Number 616003
Gdansk, 80-952, Poland
Investigational Site Number 616007
Krakow, 31-159, Poland
Investigational Site Number 616001
Lodz, 90-153, Poland
Investigational Site Number 616005
Lodz, 90-153, Poland
Investigational Site Number 616008
Warsaw, 00-013, Poland
Investigational Site Number 643003
Moscow, 105229, Russia
Investigational Site Number 643002
Moscow, 109240, Russia
Investigational Site Number 643007
Moscow, 115446, Russia
Investigational Site Number 643012
Moscow, 123182, Russia
Investigational Site Number 643001
Moscow, 125367, Russia
Investigational Site Number 643006
Novosibirsk, 630091, Russia
Investigational Site Number 643010
Saint Petersburg, 194354, Russia
Investigational Site Number 643011
Saint Petersburg, 196356, Russia
Investigational Site Number 643009
Saint Petersburg, 197022, Russia
Investigational Site Number 643008
Yaroslavl, 150003, Russia
Investigational Site Number 710001
Cape Town, 7531, South Africa
Investigational Site Number 710002
Cape Town, 7764, South Africa
Investigational Site Number 410002
Bucheon-si, 420-767, South Korea
Investigational Site Number 410003
Cheongju-si, 361-711, South Korea
Investigational Site Number 410004
Seoul, 120-752, South Korea
Investigational Site Number 410005
Seoul, 138-736, South Korea
Investigational Site Number 410001
Suwon, 443-721, South Korea
Investigational Site Number 724005
Barcelona, 08025, Spain
Investigational Site Number 724002
Barcelona, 08035, Spain
Investigational Site Number 724001
Barcelona, 08036, Spain
Investigational Site Number 724004
Cáceres, 10003, Spain
Investigational Site Number 724006
Pozuelo de Alarcón, 28223, Spain
Investigational Site Number 724003
Sabadell, 08208, Spain
Investigational Site Number 724007
Sant Boi de Llobregat, 08830, Spain
Investigational Site Number 792011
Amasya, 53100, Turkey (Türkiye)
Investigational Site Number 792002
Ankara, 06100, Turkey (Türkiye)
Investigational Site Number 792008
Bursa, 16059, Turkey (Türkiye)
Investigational Site Number 792007
Istanbul, 34020, Turkey (Türkiye)
Investigational Site Number 792001
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number 792004
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number 792003
Istanbul, 34844, Turkey (Türkiye)
Investigational Site Number 792005
Izmir, 35040, Turkey (Türkiye)
Investigational Site Number 792013
Kırıkkale, 71450, Turkey (Türkiye)
Investigational Site Number 792006
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number 804016
Donetsk, 83099, Ukraine
Investigational Site Number 804001
Kharkiv, 61124, Ukraine
Investigational Site Number 804004
Kyiv, 03049, Ukraine
Investigational Site Number 804003
Kyiv, 03680, Ukraine
Investigational Site Number 804008
Kyiv, 03680, Ukraine
Investigational Site Number 804018
Kyiv, 03680, Ukraine
Investigational Site Number 804020
Kyiv, 03680, Ukraine
Investigational Site Number 804006
Odesa, 65025, Ukraine
Investigational Site Number 804002
Poltava, 36038, Ukraine
Investigational Site Number 804019
Vinnytsia, 21001, Ukraine
Investigational Site Number 804015
Yalta, 98603, Ukraine
Investigational Site Number 804012
Zaporizhzhya, 69118, Ukraine
Related Publications (8)
Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27.
PMID: 27130691RESULTPavord ID, Bourdin A, Papi A, Domingo C, Corren J, Altincatal A, Radwan A, Pandit-Abid N, Jacob-Nara JA, Deniz Y, Rowe PJ, Laws E, Lederer DJ, Hardin M. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023 Nov;78(11):2921-2932. doi: 10.1111/all.15792. Epub 2023 Jul 11.
PMID: 37431558DERIVEDWechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
PMID: 35636689DERIVEDBourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.
PMID: 33010038DERIVEDMaspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.
PMID: 31351189DERIVEDCorren J, Castro M, Ford LB, Bernstein JA, Jayawardena S, Maroni J, Rowe P, Amin N, Pirozzi G, Graham NMH, Khan A, Eckert L, Teper A. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019 Aug;123(2):222-224.e1. doi: 10.1016/j.anai.2019.04.028. Epub 2019 May 8. No abstract available.
PMID: 31075309DERIVEDCorren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbe A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.
PMID: 30138668DERIVEDWeinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.
PMID: 29355679DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 15, 2013
Study Start
June 1, 2013
Primary Completion
November 1, 2014
Study Completion
April 1, 2015
Last Updated
June 26, 2017
Results First Posted
June 2, 2017
Record last verified: 2017-06