Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
ATTR-ACT
A MULTICENTER, INTERNATIONAL, PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN COMPARISON TO PLACEBO IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)
3 other identifiers
interventional
441
13 countries
80
Brief Summary
This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2013
Typical duration for phase_3
80 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
November 14, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedStudy Start
First participant enrolled
December 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2018
CompletedResults Posted
Study results publicly available
April 3, 2019
CompletedApril 24, 2019
April 1, 2019
4.2 years
November 14, 2013
January 31, 2019
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hierarchical Combination of All-Cause Mortality and Frequency of Cardiovascular-Related Hospitalizations
All-cause mortality and frequency of cardiovascular hospitalization were analyzed using Finkelstein-Schoenfeld method. The method combines all-cause mortality and frequency of CV-related hospitalizations in a hierarchical fashion using all-cause mortality first. The method compares every participant with every other participant within strata, assigning a +1 to the "better" participant and a -1 to the "worse" participant and 0 if they are "tied". Participants who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. 'Win' represents a participant doing better based on hierarchical comparison. The reported unit is the total "wins" for each treatment group from performing such a hierarchical comparison across all 4 strata in the study.
Baseline up to Month 30
Secondary Outcomes (6)
All-Cause Mortality
Baseline up to Month 30
Frequency of Cardiovascular-Related Hospitalizations
Baseline to Month 30
Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 30
Baseline, Month 30
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) at Month 30
Baseline, Month 30
Number of Participants With Cardiovascular-Related Mortality
Baseline up to Month 30
- +1 more secondary outcomes
Study Arms (3)
Tafamidis - 20 mg
EXPERIMENTALActive Treatment-Low dose
Tafamidis - 80 mg
EXPERIMENTALActive Treatment-High Dose
Placebo
PLACEBO COMPARATORPlacebo control
Interventions
Eligibility Criteria
You may qualify if:
- Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement,
- Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm,
- Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry
You may not qualify if:
- A New York Heart Association (NYHA) classification of IV.
- Presence of primary (light chain) amyloidosis.
- Prior liver or heart transplantation or implanted cardiac mechanical assist device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (80)
The Kirklin Clinic
Birmingham, Alabama, 35249, United States
UAB Hospital Department of Pharmacy IDS
Birmingham, Alabama, 35249, United States
University Hospital, University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Mayo Clinic Arizona - Mayo Clinic Speciality Building
Phoenix, Arizona, 85054, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic Arizona - Mayo Clinic Building
Scottsdale, Arizona, 85259, United States
UCSD Clinical and Translational Research Institute, Investigational Drug Service
La Jolla, California, 92037-0620, United States
Altman Clinical Translational Research institute
La Jolla, California, 92037-0990, United States
Altman Clinical Translational Research Institute
La Jolla, California, 92037, United States
UCSD Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center, Investigational Drug Pharmacy Services
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Care Foundation
Los Angeles, California, 90211, United States
UCSF Cardiovascular Care and Prevention Center
San Francisco, California, 94143, United States
Stanford University Hospital and Clinics
Stanford, California, 94305, United States
UM Sylvester at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Hospital & Clinics
Miami, Florida, 33136, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Advocate Christ Medical Centre
Oak Lawn, Illinois, 60453, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
University of Maryland, School of Medicine
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
The Johns Hopkins Hospital IDS Pharmacy
Baltimore, Maryland, 21287, United States
Boston Medical Center - Cardiovascular Center, Outpatient Clinic
Boston, Massachusetts, 02118, United States
Boston Medical Center Investigational Pharmacy Services
Boston, Massachusetts, 02118, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Boston University Medical Center General Clinical Research Unit
Boston, Massachusetts, 02118, United States
Michigan Medicine,University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Pharmacy Research Supp
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
New York University Hospitals
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
New York, New York, 10029, United States
Mount Sinai Doctors Faculty Practice
New York, New York, 10029, United States
The Mount Sinai Hospital Department of Pharmacy
New York, New York, 10029, United States
Columbia University Medical Center Research Pharmacy
New York, New York, 10032, United States
Columbia University Medical Center/Clinical Cardiovascular Research Laboratory for the Elderly
New York, New York, 10034, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
OHSU Research Pharmacy Services
Portland, Oregon, 97239, United States
Oregon Health and Science University (OHSU)
Portland, Oregon, 97239, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Utah,Health Sciences Center
Salt Lake City, Utah, 84132, United States
VCU Medical Center - Ambulatory Care Clinic
Richmond, Virginia, 23298, United States
VCU Medical Center - Main Hospital
Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Unidade de Pesquisa Clinica / Hospital Universitario Clementino Fraga Filho / UFRJ
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
University of Calgary/Foothills Medical Centre
Calgary, Alberta, T2N 4Z6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Fakultni nemocnice u sv. Anny, Nemocnicni lekarna
Brno, 656 91, Czechia
Nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna
Prague, 12808, Czechia
IKEM, Ustavni lekarna
Prague, 140 21, Czechia
IKEM
Prague, 140 21, Czechia
Hopital Antoine Beclere
Clamart, 92140, France
CHU Henri Mondor
Créteil, 94010, France
Medical University of Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
U.O. Cardiologia- Prof. Rapezzi
Bologna, 40138, Italy
Unita Operativa di Cardiologia
Brescia, 25123, Italy
S.O.D. Cardiologia Generale 1 - D.A.I. del Cuore e dei Vasi
Florence, 50134, Italy
Centro per lo Studio e la Cura Delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 8608556, Japan
Shinshu University Hospital
Nagano, 390-8621, Japan
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Hospital Universitario Puerta De Hierro - Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Universitario A Coruna
A Coruña, 15006, Spain
Medicin-Geriatrik kliniken-Skelleftea lasarett
Skellefteå, 93186, Sweden
Sjukhusvägen, Akademiska sjukhuset
Uppsala, 751 85, Sweden
St Bartholomew's Hospital-Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
St. George's Hospital (St George's Healthcare NHS Trust)
London, SW17 0QT, United Kingdom
St. George's University of London
London, SW17 0RE, United Kingdom
Related Publications (27)
Damy T, Wang R, Maurer MS, Gillmore JD, Fontana M. Long-term efficacy of tafamidis in patients with transthyretin amyloid cardiomyopathy by National Amyloidosis Centre stage. Eur J Heart Fail. 2025 Jun 9. doi: 10.1002/ejhf.3696. Online ahead of print.
PMID: 40488446DERIVEDGrogan M, Davis MK, Crespo Leiro MG, Sultan MB, Gundapaneni B, Angeli FS, Hanna M. The effect of long-term tafamidis treatment on quality of life in people with transthyretin amyloid cardiomyopathy (ATTR-CM): A plain language summary. Future Cardiol. 2024;20(11-12):595-603. doi: 10.1080/14796678.2024.2391250. Epub 2024 Sep 11.
PMID: 39258729DERIVEDWitteles R, Jefferies JL, Kapa S, Cappelli F, Sultan MB, Gundapaneni B, Davis MK, Garcia-Pavia P. Atrial Fibrillation as a Prognostic Factor for All-Cause Mortality in Patients With Transthyretin Amyloid Cardiomyopathy. JACC CardioOncol. 2024 Apr 30;6(4):592-598. doi: 10.1016/j.jaccao.2024.03.007. eCollection 2024 Aug.
PMID: 39239341DERIVEDHanna M, Fine NM, Gundapaneni B, Sultan MB, Witteles RM. Improvements in Efficacy Measures With Tafamidis in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial. JACC Adv. 2022 Dec 14;1(5):100148. doi: 10.1016/j.jacadv.2022.100148. eCollection 2022 Dec.
PMID: 38939456DERIVEDDrachman B, Damy T, Hanna M, Wang R, Angeli FS, Garcia-Pavia P. Long-term tafamidis efficacy in patients with transthyretin amyloid cardiomyopathy by baseline left ventricular ejection fraction. Eur J Heart Fail. 2024 Sep;26(9):2038-2046. doi: 10.1002/ejhf.3330. Epub 2024 Jun 26.
PMID: 38932583DERIVEDSperry BW, Sultan MB, Gundapaneni B, Tai SS, Witteles RM. Effect of Tafamidis on Renal Function in Patients With Transthyretin Amyloid Cardiomyopathy in ATTR-ACT. JACC CardioOncol. 2024 Apr 16;6(2):300-306. doi: 10.1016/j.jaccao.2024.02.007. eCollection 2024 Apr.
PMID: 38774010DERIVEDShah SJ, Fine N, Garcia-Pavia P, Klein AL, Fernandes F, Weissman NJ, Maurer MS, Boman K, Gundapaneni B, Sultan MB, Elliott P. Effect of Tafamidis on Cardiac Function in Patients With Transthyretin Amyloid Cardiomyopathy: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial. JAMA Cardiol. 2024 Jan 1;9(1):25-34. doi: 10.1001/jamacardio.2023.4147.
PMID: 37966817DERIVEDGarcia-Pavia P, Sultan MB, Gundapaneni B, Sekijima Y, Perfetto F, Hanna M, Witteles R. Tafamidis Efficacy Among Octogenarian Patients in the Phase 3 ATTR-ACT and Ongoing Long-Term Extension Study. JACC Heart Fail. 2024 Jan;12(1):150-160. doi: 10.1016/j.jchf.2023.08.032. Epub 2023 Nov 8.
PMID: 37943223DERIVEDElliott P, Gundapaneni B, Sultan MB, Ines M, Garcia-Pavia P. Improved long-term survival with tafamidis treatment in patients with transthyretin amyloid cardiomyopathy and severe heart failure symptoms. Eur J Heart Fail. 2023 Nov;25(11):2060-2064. doi: 10.1002/ejhf.2974. Epub 2023 Jul 26.
PMID: 37434378DERIVEDBhambri R, Colavecchia AC, Bruno M, Chen Y, Alvir J, Roy A, Kemner J, Crowley A, Benjumea D, Gilstrap L. Real-World Characteristics of Patients with Wild-Type Transthyretin Amyloid Cardiomyopathy: An Analysis of Electronic Healthcare Records in the United States. Am J Cardiovasc Drugs. 2023 Mar;23(2):197-206. doi: 10.1007/s40256-022-00563-4. Epub 2023 Feb 13.
PMID: 36780092DERIVEDSperry BW, Hanna M, Maurer MS, Nativi-Nicolau J, Floden L, Stewart M, Wyrwich KW, Barsdorf AI, Kapadia H, Spertus JA. Association of Tafamidis With Health Status in Patients With ATTR Cardiac Amyloidosis: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):275-280. doi: 10.1001/jamacardio.2022.5251.
PMID: 36723935DERIVEDElliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-term survival in people with transthyretin amyloid cardiomyopathy who took tafamidis: A Plain Language Summary. Future Cardiol. 2023 Jan;19(1):7-17. doi: 10.2217/fca-2022-0096. Epub 2023 Jan 30.
PMID: 36715498DERIVEDTess DA, Maurer TS, Li Z, Bulawa C, Fleming J, Moody AT. Relationship of binding-site occupancy, transthyretin stabilisation and disease modification in patients with tafamidis-treated transthyretin amyloid cardiomyopathy. Amyloid. 2023 Jun;30(2):208-219. doi: 10.1080/13506129.2022.2145876. Epub 2022 Nov 18.
PMID: 36399070DERIVEDMaeda-Ogata S, Tahara N, Tahara A, Bekki M, Honda A, Sugiyama Y, Igata S, Abe T, Sekijima Y, Ueda M, Ando Y, Fukumoto Y. Treatment response to Tafamidis quantitatively assessed by serial bone scintigraphy in transthyretin amyloid cardiomyopathy. J Nucl Cardiol. 2023 Feb;30(1):403-404. doi: 10.1007/s12350-022-03137-8. Epub 2022 Nov 8. No abstract available.
PMID: 36348245DERIVEDRozenbaum MH, Tran D, Bhambri R, Nativi-Nicolau J. Annual Cardiovascular-Related Hospitalization Days Avoided with Tafamidis in Patients with Transthyretin Amyloid Cardiomyopathy. Am J Cardiovasc Drugs. 2022 Jul;22(4):445-450. doi: 10.1007/s40256-022-00526-9. Epub 2022 Mar 30.
PMID: 35353352DERIVEDNativi-Nicolau J, Judge DP, Hoffman JE, Gundapaneni B, Keohane D, Sultan MB, Grogan M. How did transthyretin amyloid cardiomyopathy progress in patients who took placebo in the study ATTR-ACT? A plain language summary. Future Cardiol. 2022 Mar 17. doi: 10.2217/fca-2021-0150. Online ahead of print.
PMID: 35297655DERIVEDElliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy. Circ Heart Fail. 2022 Jan;15(1):e008193. doi: 10.1161/CIRCHEARTFAILURE.120.008193. Epub 2021 Dec 20.
PMID: 34923848DERIVEDHanna M, Damy T, Grogan M, Stewart M, Gundapaneni B, Sultan MB, Maurer MS. Tafamidis and quality of life in people with transthyretin amyloid cardiomyopathy in the study ATTR-ACT: A plain language summary. Future Cardiol. 2022 Mar;18(3):165-172. doi: 10.2217/fca-2021-0095. Epub 2021 Nov 15.
PMID: 34779246DERIVEDRozenbaum MH, Garcia A, Grima D, Tran D, Bhambri R, Stewart M, Li B, Heeg B, Postma M, Masri A. Health impact of tafamidis in transthyretin amyloid cardiomyopathy patients: an analysis from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and the open-label long-term extension studies. Eur Heart J Qual Care Clin Outcomes. 2022 Aug 17;8(5):529-538. doi: 10.1093/ehjqcco/qcab031.
PMID: 33895806DERIVEDVong C, Boucher M, Riley S, Harnisch LO. Modeling of Survival and Frequency of Cardiovascular-Related Hospitalization in Patients with Transthyretin Amyloid Cardiomyopathy Treated with Tafamidis. Am J Cardiovasc Drugs. 2021 Sep;21(5):535-543. doi: 10.1007/s40256-021-00464-y. Epub 2021 Mar 26.
PMID: 33770392DERIVEDMiller AB, Januzzi JL, O'Neill BJ, Gundapaneni B, Patterson TA, Sultan MB, Lopez-Sendon J. Causes of Cardiovascular Hospitalization and Death in Patients With Transthyretin Amyloid Cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial [ATTR-ACT]). Am J Cardiol. 2021 Jun 1;148:146-150. doi: 10.1016/j.amjcard.2021.02.035. Epub 2021 Mar 3.
PMID: 33667442DERIVEDRapezzi C, Elliott P, Damy T, Nativi-Nicolau J, Berk JL, Velazquez EJ, Boman K, Gundapaneni B, Patterson TA, Schwartz JH, Sultan MB, Maurer MS. Efficacy of Tafamidis in Patients With Hereditary and Wild-Type Transthyretin Amyloid Cardiomyopathy: Further Analyses From ATTR-ACT. JACC Heart Fail. 2021 Feb;9(2):115-123. doi: 10.1016/j.jchf.2020.09.011. Epub 2020 Dec 9.
PMID: 33309574DERIVEDHanna M, Damy T, Grogan M, Stewart M, Gundapaneni B, Patterson TA, Schwartz JH, Sultan MB, Maurer MS. Impact of Tafamidis on Health-Related Quality of Life in Patients With Transthyretin Amyloid Cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Am J Cardiol. 2021 Feb 15;141:98-105. doi: 10.1016/j.amjcard.2020.10.066. Epub 2020 Nov 19.
PMID: 33220323DERIVEDDamy T, Garcia-Pavia P, Hanna M, Judge DP, Merlini G, Gundapaneni B, Patterson TA, Riley S, Schwartz JH, Sultan MB, Witteles R. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021 Feb;23(2):277-285. doi: 10.1002/ejhf.2027. Epub 2020 Nov 12.
PMID: 33070419DERIVEDLi B, Alvir J, Stewart M. Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial. Cardiol Ther. 2020 Dec;9(2):535-540. doi: 10.1007/s40119-020-00179-2. Epub 2020 Jun 10.
PMID: 32524297DERIVEDMaurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
PMID: 30145929DERIVEDMaurer MS, Elliott P, Merlini G, Shah SJ, Cruz MW, Flynn A, Gundapaneni B, Hahn C, Riley S, Schwartz J, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Design and Rationale of the Phase 3 ATTR-ACT Clinical Trial (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Circ Heart Fail. 2017 Jun;10(6):e003815. doi: 10.1161/CIRCHEARTFAILURE.116.003815.
PMID: 28611125DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2013
First Posted
November 26, 2013
Study Start
December 9, 2013
Primary Completion
February 7, 2018
Study Completion
February 7, 2018
Last Updated
April 24, 2019
Results First Posted
April 3, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.