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A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)

Primary Purpose

Dilated Cardiomyopathy, Lamin A/C Gene Mutation

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARRY-371797 (PF-07265803)
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring cardiomyopathy, Lamin Type A, heart failure, ARRY-797, C4411002

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Selected Key Inclusion Criteria:

  • Patients with symptomatic lamin A/C protein (LMNA)-related cardiomyopathy Class II/III/ or Class IV defined as:
  • Gene positive for a pathogenic, likely pathogenic, or VUS mutation in the LMNA gene as determined by an accredited clinical laboratory.
  • Evidence of cardiac impairment in LVEF <= 50%
  • Patient will have an implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D). ICD implanted at least 4 weeks prior to initiation of study treatment or CRT-D initiated at least 6 months prior to initiation of study treatment and defibrillation function activated at least 4 weeks prior to initiation of study treatment.
  • Class II/III patients must have objective functional impairment evidenced by a reduction in 6-minute walk test (6MWT); a. Screening: 6MWT distance >100 m but ≤450 m, AND b. Day -1 visit: 6MWT distance >100 m but ≤485 m, AND c. Baseline visit (Day 1): 6MWT distance >100 m but ≤485
  • Class II/III patients must be stable for at least 3 months
  • Stable medical and/or device therapy consistent with regional American Heart Association (AHA) / American College of Cardiology (ACC) or European Society of Cardiology (ESC) guidelines at the investigator discretion, without change in heart failure drug(s) dose in the past 1 month.
  • Patients must meet acceptable hematology, hepatic and renal laboratory values within 35 days prior to Day 1 as specified in the protocol.

Selected Key Exclusion Criteria:

  • Presence of other form(s) of cardiomyopathy contributing to HF (eg, inflammatory or infiltrative cardiomyopathy), clinically significant cardiac anatomic abnormality (eg,LV aneurysm), clinically significant coronary artery disease (eg, coronary revascularization, exercise induced angina) or uncorrected, hemodynamically significant (ie, moderate-severe) primary structural valvular disease not due to HF, per investigator judgment.
  • Currently receiving intermittent or continuous IV inotrope infusion, or presence of a ventricular assist device, or history of prior heart transplantation. Participants listed for cardiac transplantation may be enrolled provided transplantation is not likely to occur in the next 6 months.
  • Myocardial infarction, cardiac surgical procedures (other than for pacemaker/ICD/CRT-D implantation or replacement), acute coronary syndrome, serious systemic infection with evidence of septicemia, or any major surgical procedure requiring general anesthesia within 3 months prior to screening.
  • Currently receiving or deemed at high risk of requiring chronic renal replacement therapy (eg, hemodialysis or peritoneal dialysis) within 6 months.
  • Initiation of CRT within 6 months prior to screening.
  • Treatment with any investigational agent(s) for HF within 35 days prior to Day 1.
  • Malignancy that is active or has been diagnosed within 3 years prior to screening, except surgically curatively resected in situ malignancies or surgically cured early breast cancer, prostate cancer, skin cancer (basal cell carcinoma, squamous cell carcinoma), thyroid cancer, or cervical cancer, or, with prior review by the medical monitor, other early stage surgically curatively resected malignancies with less than a 20% expected 2 year recurrence rate.
  • Non-cardiac condition that limits lifespan to < 1 year.
  • Serum positive for hepatitis B surface antigen, viremic hepatitis C, or human immunodeficiency virus (HIV) at screening.

Sites / Locations

  • University of Alabama at Birmingham Hospital
  • University of Alabama at Birmingham the Kirklin Clinic
  • IDS Pharmacy at UAB Hospital
  • Cardiovascular Clinical Trials Unit
  • CB Flock Research Corporation
  • Chandler Regional Medical Center
  • Valley Heart Rhythm Specialists, PLLC
  • Cardiovascular and Stem Cell Consultants
  • Cardiovascular Research Clinic
  • Dignity Health, Mercy Gilbert Medical Center
  • Mercy Gilbert Medical Center
  • Children's Clinic
  • Banner - Banner University Medical Center South
  • Banner - University Medical Center Tucson
  • Banner University Medicine North
  • Banner University Medical Center Tuscon
  • University of Arizona Sarver Heart Center
  • Ahmanson Cardiomyopathy Center Cardiovascular Genetics
  • Stanford Hospital and Clinics
  • University of Colorado Academic Offices Building
  • University of Colorado Clinical and Translational Research Center
  • University of Colorado Hospital
  • Medstar Washington Hospital Center
  • Innovative Research of West Florida
  • University of South Florida
  • USF Health
  • Florida Cardiovascular Institute PA
  • Centers for Heart Failure Therapy
  • Emory University Hospital
  • Columbus Cardiology Associates Research - Centricity Research - HyperCore - PPDS
  • Columbus Cardiology Associates Research - IACT - HyperCore - PPDS
  • Columbus Regional Research Institute at Talbotton - Centricity Research - HyperCore - PPDS
  • Columbus Regional Research Institute
  • Saint Luke's Idaho Cardiology Associates
  • Brigham and Women's Hospital
  • MyMichigan Medical Center Midland
  • Washington University Center For Advanced Medicine
  • Washington University Center for Outpatient Health
  • Washington University School of Medicine
  • Rutgers New Jersey Medical School - Doctors Office Center
  • Newark Beth Israel Medical Center
  • NYU School of Medicine / NYU Langone Health
  • Columbia University Irving Medical Center
  • Columbia University/Presbyterian Hospital - Vivian & Seymour Milstein Family Heart Center
  • The Cleveland Clinic Foundation
  • Ohio State University Wexner Medical Center
  • University of Pennsylvania Hospital
  • Medical University of South Carolina - PPDS
  • Medical University of South Carolina - PPDS
  • Stern Cardiovascular Foundation Inc
  • Tennessee Center for Clinical Trials
  • Baylor Scott and White Heart and Vascular Hospital
  • Baylor Annette C and Harold C Simmons Transplant Institute
  • Intermountain Medical Center
  • University of Washington Medical Center
  • Meriter Hospital
  • Fundacion Favaloro para la Docencia e Investigacion Medica
  • Instituto CAICI
  • Hospital Provincial Del Centenario
  • Hospital Británico de Buenos Aires
  • Hospital Provincial Dr Jose Maria Cullen
  • Onze-Lieve-Vrouwziekenhuis
  • UZ Leuven
  • St. Paul's Hospital
  • Nova Scotia Health Authority (Capital District Health Authority)
  • NSHA QEII Health Sciences Halifax Infirmary
  • University of Ottawa Heart Institute
  • Kawartha Cardiology Clinical Trials
  • Clinical Laboratories of Montreal Heart Institute
  • Centre Intégré Universitaire de santé et de services sociaux de l'Estrie Centre hospitalier
  • Ospedale Di Cattinara
  • Azienda Ospedaliera Sant'Andrea
  • Ospedale Santa Maria Della Misericordia Perugia
  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Azienda Ospedaliera Universitaria Careggi
  • Lacopo Olivotto, Azienda Ospedaliera Universitaria Careggi
  • A.O.U. di Perugia Ospedale Santa Maria della Misericordia
  • AO Ospedale Policlinico Consorziale di Bari
  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Azienda Ospedaliera Universitaria Careggi
  • IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
  • A.O.U. di Perugia Ospedale Santa Maria Della Misericordia
  • A.O.U. di Perugia Ospedale Santa Maria della Misericordia
  • Presidio Ospedaliero Madonna del Soccorso
  • Ospedale Di Cattinara
  • Hospital Boutique Riobamba
  • Cardiolink Clin Trials S.C.
  • Christus Muguerza Hospital Alta Especialidad
  • Fundación de Atención e Investigación Médica Lindavista S.C.
  • Amsterdam UMC, Location Academic Medical Center
  • Sykehuset Innlandet HF Hamar
  • Oslo University Hospital, Rikshospitalet
  • Centro de Farmacovigilancia de Galicia
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Hospital Universitario Virgen de la Arrixaca
  • Complejo Hospitalario Universitario de Vigo - H. Alvaro Cunqueiro
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Universitario Vall d'Hebrón - PPDS
  • Hospital Clinic de Barcelona
  • Hospital General Universitario Reina Sofia
  • C.H. Regional Reina Sofia - PPDS
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Universitario Son Llatzer
  • Queen Elizabeth University Hospital - PPDS
  • St Bartholomew's Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1 Double-blind Treatment

Part 2 Open-label Treatment

Arm Description

ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally

ARRY-371797 (PF-07265803) tablet orally

Outcomes

Primary Outcome Measures

Change from baseline in 6-minute walk test (6MWT)
The 6 MWT measures the distance walked over a total of six minutes on a hard, and flat surface.

Secondary Outcome Measures

Change from baseline in 6-minute walk test (6MWT)
The 6 MWT measures the distance walked over a total of six minutes on a hard, and flat surface.
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) domain
The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The PL is a single domain consisting of 7 items scored using a range of 0 - 100, in which higher scores reflect better physical functioning status.
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) as measured by Total Symptom Score (TSS) domain
The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The TSS is a combined score based upon the symptom burden, symptom frequency and symptom severity domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.
Change from baseline in Patient Global Impression score of Severity(PGI-S) of heart failure symptoms and physical activity limitations
Measured by the scale of: none, mild, moderate, severe or very severe (listed from better to worse)
Change from baseline in Patient Global Impression score of Change (PGI-C) in heart failure symptoms and physical activity limitations
Measured by the scale of: very much better, moderately better, a little better, no change, a little worse, moderately worse, very much worse (listed from better to worse).
Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Evaluate the impact of ARRY-371797 (PF-07265803) on composite endpoint of all-cause mortality, or worsening heart failure (WHF).
Defined as the time from randomization to the first occurrence of any event of death due to any cause, or worsening heart failure (HF-related hospitalization or HF-related urgent care visit).
Evaluate the impact of ARRY-371797 (PF-07265803) on overall survival (OS).
Defined as the time from randomization until death due to any cause.
Evaluate the safety of ARRY-371797 (PF-07265803).
Incidence and severity of adverse events. Changes in clinical safety laboratory tests, vital signs, and 12 lead ECGs, and incidence and severity of ventricular or atrial arrhythmias detected.

Full Information

First Posted
February 1, 2018
Last Updated
June 5, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03439514
Brief Title
A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
Acronym
REALM-DCM
Official Title
A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
The Sponsor terminated the study due to futility. The decision to stop the study was not based on safety concerns.
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
October 13, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA). The study will further evaluate a dose level of study drug (ARRY-371797) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may receive open-label treatment with ARRY-371797.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy, Lamin A/C Gene Mutation
Keywords
cardiomyopathy, Lamin Type A, heart failure, ARRY-797, C4411002

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The study will be conducted in 2 parts: a randomized, double-blind treatment period for at least 24 weeks, followed by an ARRY-371797 (PF-07265803) open-label treatment period.
Masking
ParticipantInvestigator
Masking Description
During the randomized, double-blind period, patients, Investigators, site personnel and the sponsor personnel directly involved with the conduct of the study will remain blinded to assigned treatment, except for regulatory reporting requirements.
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Double-blind Treatment
Arm Type
Experimental
Arm Description
ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally
Arm Title
Part 2 Open-label Treatment
Arm Type
Experimental
Arm Description
ARRY-371797 (PF-07265803) tablet orally
Intervention Type
Drug
Intervention Name(s)
ARRY-371797 (PF-07265803)
Intervention Description
400 mg twice daily (BID)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
BID
Primary Outcome Measure Information:
Title
Change from baseline in 6-minute walk test (6MWT)
Description
The 6 MWT measures the distance walked over a total of six minutes on a hard, and flat surface.
Time Frame
at Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in 6-minute walk test (6MWT)
Description
The 6 MWT measures the distance walked over a total of six minutes on a hard, and flat surface.
Time Frame
at Weeks 4 and 12
Title
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) domain
Description
The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The PL is a single domain consisting of 7 items scored using a range of 0 - 100, in which higher scores reflect better physical functioning status.
Time Frame
at Weeks 12 and 24
Title
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) as measured by Total Symptom Score (TSS) domain
Description
The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The TSS is a combined score based upon the symptom burden, symptom frequency and symptom severity domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.
Time Frame
at Weeks 12 and 24
Title
Change from baseline in Patient Global Impression score of Severity(PGI-S) of heart failure symptoms and physical activity limitations
Description
Measured by the scale of: none, mild, moderate, severe or very severe (listed from better to worse)
Time Frame
at Weeks 12 and 24
Title
Change from baseline in Patient Global Impression score of Change (PGI-C) in heart failure symptoms and physical activity limitations
Description
Measured by the scale of: very much better, moderately better, a little better, no change, a little worse, moderately worse, very much worse (listed from better to worse).
Time Frame
at Weeks 12 and 24
Title
Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame
at Weeks 4, 12 and 24
Title
Evaluate the impact of ARRY-371797 (PF-07265803) on composite endpoint of all-cause mortality, or worsening heart failure (WHF).
Description
Defined as the time from randomization to the first occurrence of any event of death due to any cause, or worsening heart failure (HF-related hospitalization or HF-related urgent care visit).
Time Frame
From randomization up to 80 months.
Title
Evaluate the impact of ARRY-371797 (PF-07265803) on overall survival (OS).
Description
Defined as the time from randomization until death due to any cause.
Time Frame
From randomization up to 80 months.
Title
Evaluate the safety of ARRY-371797 (PF-07265803).
Description
Incidence and severity of adverse events. Changes in clinical safety laboratory tests, vital signs, and 12 lead ECGs, and incidence and severity of ventricular or atrial arrhythmias detected.
Time Frame
From randomization up to 80 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Selected Key Inclusion Criteria: Patients with symptomatic lamin A/C protein (LMNA)-related cardiomyopathy Class II/III/ or Class IV defined as: Gene positive for a pathogenic, likely pathogenic, or VUS mutation in the LMNA gene as determined by an accredited clinical laboratory. Evidence of cardiac impairment in LVEF <= 50% Patient will have an implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D). ICD implanted at least 4 weeks prior to initiation of study treatment or CRT-D initiated at least 6 months prior to initiation of study treatment and defibrillation function activated at least 4 weeks prior to initiation of study treatment. Class II/III patients must have objective functional impairment evidenced by a reduction in 6-minute walk test (6MWT); a. Screening: 6MWT distance >100 m but ≤450 m, AND b. Day -1 visit: 6MWT distance >100 m but ≤485 m, AND c. Baseline visit (Day 1): 6MWT distance >100 m but ≤485 Class II/III patients must be stable for at least 3 months Stable medical and/or device therapy consistent with regional American Heart Association (AHA) / American College of Cardiology (ACC) or European Society of Cardiology (ESC) guidelines at the investigator discretion, without change in heart failure drug(s) dose in the past 1 month. Patients must meet acceptable hematology, hepatic and renal laboratory values within 35 days prior to Day 1 as specified in the protocol. Selected Key Exclusion Criteria: Presence of other form(s) of cardiomyopathy contributing to HF (eg, inflammatory or infiltrative cardiomyopathy), clinically significant cardiac anatomic abnormality (eg,LV aneurysm), clinically significant coronary artery disease (eg, coronary revascularization, exercise induced angina) or uncorrected, hemodynamically significant (ie, moderate-severe) primary structural valvular disease not due to HF, per investigator judgment. Currently receiving intermittent or continuous IV inotrope infusion, or presence of a ventricular assist device, or history of prior heart transplantation. Participants listed for cardiac transplantation may be enrolled provided transplantation is not likely to occur in the next 6 months. Myocardial infarction, cardiac surgical procedures (other than for pacemaker/ICD/CRT-D implantation or replacement), acute coronary syndrome, serious systemic infection with evidence of septicemia, or any major surgical procedure requiring general anesthesia within 3 months prior to screening. Currently receiving or deemed at high risk of requiring chronic renal replacement therapy (eg, hemodialysis or peritoneal dialysis) within 6 months. Initiation of CRT within 6 months prior to screening. Treatment with any investigational agent(s) for HF within 35 days prior to Day 1. Malignancy that is active or has been diagnosed within 3 years prior to screening, except surgically curatively resected in situ malignancies or surgically cured early breast cancer, prostate cancer, skin cancer (basal cell carcinoma, squamous cell carcinoma), thyroid cancer, or cervical cancer, or, with prior review by the medical monitor, other early stage surgically curatively resected malignancies with less than a 20% expected 2 year recurrence rate. Non-cardiac condition that limits lifespan to < 1 year. Serum positive for hepatitis B surface antigen, viremic hepatitis C, or human immunodeficiency virus (HIV) at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham the Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
IDS Pharmacy at UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Cardiovascular Clinical Trials Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
CB Flock Research Corporation
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Chandler Regional Medical Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Valley Heart Rhythm Specialists, PLLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Cardiovascular and Stem Cell Consultants
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297-0425
Country
United States
Facility Name
Cardiovascular Research Clinic
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297-0425
Country
United States
Facility Name
Dignity Health, Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297-0425
Country
United States
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Children's Clinic
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Banner - Banner University Medical Center South
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
Facility Name
Banner - University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Banner University Medicine North
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Banner University Medical Center Tuscon
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arizona Sarver Heart Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Ahmanson Cardiomyopathy Center Cardiovascular Genetics
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Academic Offices Building
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Clinical and Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Innovative Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-3601
Country
United States
Facility Name
USF Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Cardiovascular Institute PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Centers for Heart Failure Therapy
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Columbus Cardiology Associates Research - Centricity Research - HyperCore - PPDS
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-6877
Country
United States
Facility Name
Columbus Cardiology Associates Research - IACT - HyperCore - PPDS
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-6877
Country
United States
Facility Name
Columbus Regional Research Institute at Talbotton - Centricity Research - HyperCore - PPDS
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-8946
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Saint Luke's Idaho Cardiology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6246
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MyMichigan Medical Center Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Washington University Center For Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers New Jersey Medical School - Doctors Office Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
NYU School of Medicine / NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Columbia University/Presbyterian Hospital - Vivian & Seymour Milstein Family Heart Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8911
Country
United States
Facility Name
Medical University of South Carolina - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Stern Cardiovascular Foundation Inc
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennessee Center for Clinical Trials
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Baylor Scott and White Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Baylor Annette C and Harold C Simmons Transplant Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
Fundacion Favaloro para la Docencia e Investigacion Medica
City
Buenos Aires
State/Province
Ciudad Autónoma DE Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Instituto CAICI
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000 PBJ
Country
Argentina
Facility Name
Hospital Provincial Del Centenario
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000KDS
Country
Argentina
Facility Name
Hospital Británico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Hospital Provincial Dr Jose Maria Cullen
City
Santa Fe
ZIP/Postal Code
S3000EOZ
Country
Argentina
Facility Name
Onze-Lieve-Vrouwziekenhuis
City
Aalst
State/Province
Oost-vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Nova Scotia Health Authority (Capital District Health Authority)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
NSHA QEII Health Sciences Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Kawartha Cardiology Clinical Trials
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
Clinical Laboratories of Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Intégré Universitaire de santé et de services sociaux de l'Estrie Centre hospitalier
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Ospedale Di Cattinara
City
Trieste
State/Province
Friuli-venezia Giulia
ZIP/Postal Code
34149
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Ospedale Santa Maria Della Misericordia Perugia
City
Perugia - Località S. Andrea Delle Fratte
State/Province
Perugia
ZIP/Postal Code
6132
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo di Pavia
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Lacopo Olivotto, Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Tuscany
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O.U. di Perugia Ospedale Santa Maria della Misericordia
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
AO Ospedale Policlinico Consorziale di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
A.O.U. di Perugia Ospedale Santa Maria Della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
A.O.U. di Perugia Ospedale Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Presidio Ospedaliero Madonna del Soccorso
City
San Benedetto del Tronto
ZIP/Postal Code
63074
Country
Italy
Facility Name
Ospedale Di Cattinara
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Facility Name
Hospital Boutique Riobamba
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07300
Country
Mexico
Facility Name
Cardiolink Clin Trials S.C.
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Christus Muguerza Hospital Alta Especialidad
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Fundación de Atención e Investigación Médica Lindavista S.C.
City
Ciudad de México
ZIP/Postal Code
07300
Country
Mexico
Facility Name
Amsterdam UMC, Location Academic Medical Center
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Sykehuset Innlandet HF Hamar
City
Hamar
ZIP/Postal Code
2318
Country
Norway
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Centro de Farmacovigilancia de Galicia
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15781
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo - H. Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Son Llatzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Queen Elizabeth University Hospital - PPDS
City
Glasgow
State/Province
Glasgow CITY
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=ARRAY-797-301
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

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