PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

NCT01314313 | Completed Results DMC FDA Device

• 1 other identifier: 2010-12 PIIA
• Study Type: interventional
• Target: 2,032
• Locations: 2 countries
• Sites: 57

Brief Summary

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

SAPIEN XT; Transfemoral; Transapical; Transaortic; NovaFlex; TAVI; Aortic Stenosis; THV; Aortic Valve; Transcatheter Heart Valve; TAVR

Outcome Measures

Primary Outcomes (1)

• All-cause Death or Disabling Stroke to Two Years

  All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)

  2 Years

Secondary Outcomes (5)

• Adjusted Days Alive and Out of Hospital (DAOH) to Two Years

  2 years

• Total Aortic Regurgitation (AR) at 2 Years

  2 years

• 6MWT Change From Baseline

  Baseline and 2 years

• NYHA Classification at 2 Years

  2 years

• Effective Orifice Area (EOA)

  2 years

Study Arms (2)

PIIA - SAPIEN XT

EXPERIMENTAL

PIIA is operable group

Device: TAVR Implantation with SAPIEN XT

Control: SAVR

ACTIVE COMPARATOR

SAVR (surgical aortic valve replacement) is the control arm

Device: SAVR Implantation

Interventions

TAVR Implantation with SAPIEN XT DEVICE

Operable Group with SAPIEN XT

PIIA - SAPIEN XT

SAVR Implantation DEVICE

Control Group

Control: SAVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
• Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
• The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
• The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
• The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
• Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

You may not qualify if:

• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
• Preexisting mechanical or bioprosthetic valve in any position (except NR3).
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
• Heart team assessment of inoperability (including examining cardiac surgeon).

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (57)

Arkansas Heart Hospital/Clinic

Little Rock, Arkansas, 72211, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mercy General Hospital

Sacramento, California, 95816, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Miami Hospital Miller School of Medicine

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northshore

Evanston, Illinois, 60201, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Indiana University Health-Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

The Jewish Hospital Medical Center

Louisville, Kentucky, 40202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic-Saint Marys Hospital

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital - Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cooper University

Camden, New Jersey, 08103, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

New York Presbyterian Hospital - Cornell

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

East Carolina Heart Institute at East Carolina University

Greenville, North Carolina, 27834, United States

Location

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Heart & Vascular Institute at Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Austin Heart, PLLC

Austin, Texas, 78756, United States

Location

The Heart Hospital Baylor Plano

Dallas, Texas, 75093, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio (UTHSCSA)

San Antonio, Texas, 78229-3900, United States

Location

IHC Health Services Inc. dba Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V465, Canada

Location

Related Publications (24)

• Madhavan MV, Kodali SK, Thourani VH, Makkar R, Mack MJ, Kapadia S, Webb JG, Cohen DJ, Herrmann HC, Williams M, Greason K, Pibarot P, Hahn RT, Jaber W, Xu K, Alu M, Smith CR, Leon MB. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2023 Jul 11;82(2):109-123. doi: 10.1016/j.jacc.2023.04.049.

  PMID: 37407110 DERIVED

• Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.

  PMID: 35595203 DERIVED

• Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e007948. doi: 10.1161/CIRCOUTCOMES.121.007948. Epub 2022 Jan 18.

  PMID: 35041482 DERIVED

• Abbas AE, Ternacle J, Pibarot P, Xu K, Alu M, Rogers E, Hahn RT, Leon M, Thourani VH. Impact of Flow on Prosthesis-Patient Mismatch Following Transcatheter and Surgical Aortic Valve Replacement. Circ Cardiovasc Imaging. 2021 Aug;14(8):e012364. doi: 10.1161/CIRCIMAGING.120.012364. Epub 2021 Aug 13.

  PMID: 34387097 DERIVED

• Cremer PC, Wang TKM, Rodriguez LL, Lindman BR, Zhang Y, Zajarias A, Hahn RT, Lerakis S, Malaisrie SC, Douglas PS, Pibarot P, Svensson LG, Kapadia S, Leon MB, Jaber WA; PARTNER II Investigators. Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial. Circ Cardiovasc Interv. 2021 Aug;14(8):e010437. doi: 10.1161/CIRCINTERVENTIONS.120.010437. Epub 2021 Jul 16.

  PMID: 34266311 DERIVED

• Brener MI, George I, Kosmidou I, Nazif T, Zhang Z, Dizon JM, Garan H, Malaisrie SC, Makkar R, Mack M, Szeto WY, Fearon WF, Thourani VH, Leon MB, Kodali S, Biviano AB. Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials. J Am Heart Assoc. 2021 Apr 6;10(7):e019584. doi: 10.1161/JAHA.120.019584. Epub 2021 Mar 23.

  PMID: 33754803 DERIVED

• Pibarot P, Ternacle J, Jaber WA, Salaun E, Dahou A, Asch FM, Weissman NJ, Rodriguez L, Xu K, Annabi MS, Guzzetti E, Beaudoin J, Bernier M, Leipsic J, Blanke P, Clavel MA, Rogers E, Alu MC, Douglas PS, Makkar R, Miller DC, Kapadia SR, Mack MJ, Webb JG, Kodali SK, Smith CR, Herrmann HC, Thourani VH, Leon MB, Hahn RT; PARTNER 2 Investigators. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020 Oct 20;76(16):1830-1843. doi: 10.1016/j.jacc.2020.08.049.

  PMID: 33059828 DERIVED

• Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, Yoon SH, Trento A, Svensson LG, Herrmann HC, Szeto WY, Miller DC, Satler L, Cohen DJ, Dewey TM, Babaliaros V, Williams MR, Kereiakes DJ, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Brown DL, Fearon WF, Russo MJ, Pibarot P, Hahn RT, Jaber WA, Rogers E, Xu K, Wheeler J, Alu MC, Smith CR, Leon MB; PARTNER 2 Investigators. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020 Jan 29;382(9):799-809. doi: 10.1056/NEJMoa1910555. Print 2020 Feb 27.

  PMID: 31995682 DERIVED

• Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.

  PMID: 31883339 DERIVED

• Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.

  PMID: 31690104 DERIVED

• Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.

  PMID: 31525069 DERIVED

• Nazif TM, Chen S, George I, Dizon JM, Hahn RT, Crowley A, Alu MC, Babaliaros V, Thourani VH, Herrmann HC, Smalling RW, Brown DL, Mack MJ, Kapadia S, Makkar R, Webb JG, Leon MB, Kodali SK. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019 Jul 14;40(27):2218-2227. doi: 10.1093/eurheartj/ehz227.

  PMID: 31505615 DERIVED

• Chakravarty T, Patel A, Kapadia S, Raschpichler M, Smalling RW, Szeto WY, Abramowitz Y, Cheng W, Douglas PS, Hahn RT, Herrmann HC, Kereiakes D, Svensson L, Yoon SH, Babaliaros VC, Kodali S, Thourani VH, Alu MC, Liu Y, McAndrew T, Mack M, Leon MB, Makkar RR. Anticoagulation After Surgical or Transcatheter Bioprosthetic Aortic Valve Replacement. J Am Coll Cardiol. 2019 Sep 3;74(9):1190-1200. doi: 10.1016/j.jacc.2019.06.058.

  PMID: 31466616 DERIVED

• Baron SJ, Wang K, House JA, Magnuson EA, Reynolds MR, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Mack MJ, Brown DL, Russo MJ, Smith CR, Webb J, Miller C, Leon MB, Cohen DJ. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk. Circulation. 2019 Feb 12;139(7):877-888. doi: 10.1161/CIRCULATIONAHA.118.035236.

  PMID: 30586747 DERIVED

• Pibarot P, Hahn RT, Weissman NJ, Arsenault M, Beaudoin J, Bernier M, Dahou A, Khalique OK, Asch FM, Toubal O, Leipsic J, Blanke P, Zhang F, Parvataneni R, Alu M, Herrmann H, Makkar R, Mack M, Smalling R, Leon M, Thourani VH, Kodali S. Association of Paravalvular Regurgitation With 1-Year Outcomes After Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve. JAMA Cardiol. 2017 Nov 1;2(11):1208-1216. doi: 10.1001/jamacardio.2017.3425.

  PMID: 28973091 DERIVED

• Baron SJ, Arnold SV, Wang K, Magnuson EA, Chinnakondepali K, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Brown DL, Mack MJ, Smith CR, Leon MB, Cohen DJ; PARTNER 2 Investigators. Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER 2 Randomized Clinical Trial. JAMA Cardiol. 2017 Aug 1;2(8):837-845. doi: 10.1001/jamacardio.2017.2039.

  PMID: 28658491 DERIVED

• Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017 May 9;69(18):2253-2262. doi: 10.1016/j.jacc.2017.02.057.

  PMID: 28473128 DERIVED

• Blanke P, Pibarot P, Hahn R, Weissman N, Kodali S, Thourani V, Parvataneni R, Dvir D, Naoum C, Norgaard BL, Douglas P, Jaber W, Khalique OK, Jilaihawi H, Mack M, Smith C, Leon M, Webb J, Leipsic J. Computed Tomography-Based Oversizing Degrees and Incidence of Paravalvular Regurgitation of a New Generation Transcatheter Heart Valve. JACC Cardiovasc Interv. 2017 Apr 24;10(8):810-820. doi: 10.1016/j.jcin.2017.02.021.

  PMID: 28427598 DERIVED

• Herrmann HC, Thourani VH, Kodali SK, Makkar RR, Szeto WY, Anwaruddin S, Desai N, Lim S, Malaisrie SC, Kereiakes DJ, Ramee S, Greason KL, Kapadia S, Babaliaros V, Hahn RT, Pibarot P, Weissman NJ, Leipsic J, Whisenant BK, Webb JG, Mack MJ, Leon MB; PARTNER Investigators. One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis. Circulation. 2016 Jul 12;134(2):130-40. doi: 10.1161/CIRCULATIONAHA.116.022797.

  PMID: 27400898 DERIVED

• Kodali S, Thourani VH, White J, Malaisrie SC, Lim S, Greason KL, Williams M, Guerrero M, Eisenhauer AC, Kapadia S, Kereiakes DJ, Herrmann HC, Babaliaros V, Szeto WY, Hahn RT, Pibarot P, Weissman NJ, Leipsic J, Blanke P, Whisenant BK, Suri RM, Makkar RR, Ayele GM, Svensson LG, Webb JG, Mack MJ, Smith CR, Leon MB. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 2016 Jul 21;37(28):2252-62. doi: 10.1093/eurheartj/ehw112. Epub 2016 Mar 31.

  PMID: 27190101 DERIVED

• Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

  PMID: 27040324 DERIVED

• Webb JG, Doshi D, Mack MJ, Makkar R, Smith CR, Pichard AD, Kodali S, Kapadia S, Miller DC, Babaliaros V, Thourani V, Herrmann HC, Bodenhamer M, Whisenant BK, Ramee S, Maniar H Jr, Kereiakes D, Xu K, Jaber WA, Menon V, Tuzcu EM, Wood D, Svensson LG, Leon MB. A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. JACC Cardiovasc Interv. 2015 Dec 21;8(14):1797-806. doi: 10.1016/j.jcin.2015.08.017.

  PMID: 26718510 DERIVED

• Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015 Sep;11 Suppl W:W86-91. doi: 10.4244/EIJV11SWA27.

  PMID: 26384204 DERIVED

• Lindman BR, Maniar HS, Jaber WA, Lerakis S, Mack MJ, Suri RM, Thourani VH, Babaliaros V, Kereiakes DJ, Whisenant B, Miller DC, Tuzcu EM, Svensson LG, Xu K, Doshi D, Leon MB, Zajarias A. Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valves II inoperable cohort. Circ Cardiovasc Interv. 2015 Apr;8(4):10.1161/CIRCINTERVENTIONS.114.002073 e002073. doi: 10.1161/CIRCINTERVENTIONS.114.002073.

  PMID: 25855679 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Tenley Koepnick
• Organization: Edwards Lifesciences

Tenley_Koepnick@edwards.com

Study Officials

• Martin B Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Craig Smith, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 17, 2024
• Last Updated: March 7, 2024
• Results First Posted: August 14, 2018

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (55); CA (2)