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

December 18, 2023 updated by: Pfizer

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Santa Fe, Argentina, S3000EOZ
        • Hospital Provincial Dr Jose Maria Cullen
    • Ciudad Autónoma DE Buenos Aires
      • Buenos Aires, Ciudad Autónoma DE Buenos Aires, Argentina, C1093AAS
        • Fundacion Favaloro para la Docencia e Investigacion Medica
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000 PBJ
        • Instituto CAICI
      • Rosario, Santa FE, Argentina, S2000KDS
        • Hospital Provincial del Centenario
      • Leuven, Belgium, 3000
        • UZ Leuven
    • Oost-vlaanderen
      • Aalst, Oost-vlaanderen, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority (Capital District Health Authority)
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • NSHA QEII Health Sciences Halifax Infirmary
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Peterborough, Ontario, Canada, K9J 0B2
        • Kawartha Cardiology Clinical Trials
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Clinical Laboratories of Montreal Heart Institute
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Centre Intégré Universitaire de santé et de services sociaux de l'Estrie Centre hospitalier
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Bari, Italy, 70124
        • AO Ospedale Policlinico Consorziale di Bari
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Pavia, Italy, 27100
        • IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
      • Perugia, Italy, 06132
        • A.O.U. di Perugia Ospedale Santa Maria della Misericordia
      • Perugia, Italy, 06156
        • A.O.U. di Perugia Ospedale Santa Maria della Misericordia
      • San Benedetto del Tronto, Italy, 63074
        • Presidio Ospedaliero Madonna del Soccorso
      • Trieste, Italy, 34149
        • Ospedale di Cattinara
    • Friuli-venezia Giulia
      • Trieste, Friuli-venezia Giulia, Italy, 34149
        • Ospedale di Cattinara
    • Lazio
      • Roma, Lazio, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Perugia
      • Perugia - Località S. Andrea Delle Fratte, Perugia, Italy, 6132
        • Ospedale Santa Maria Della Misericordia Perugia
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Lacopo Olivotto, Azienda Ospedaliera Universitaria Careggi
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • A.O.U. di Perugia Ospedale Santa Maria della Misericordia
      • Ciudad de México, Mexico, 07300
        • Fundación de Atención e Investigación Médica Lindavista S.C.
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 07300
        • Hospital Boutique Riobamba
    • Nuevo LEÓN
      • Monterrey, Nuevo LEÓN, Mexico, 64060
        • Cardiolink Clin Trials S.C.
      • Monterrey, Nuevo LEÓN, Mexico, 64060
        • Christus Muguerza Hospital Alta Especialidad
    • Noord-holland
      • Amsterdam, Noord-holland, Netherlands, 1105 AZ
        • Amsterdam UMC, Location Academic Medical Center
      • Hamar, Norway, 2318
        • Sykehuset Innlandet HF Hamar
      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet
      • A Coruna, Spain, 15006
        • Complexo Hospitalario Universitario A Coruña
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Cordoba, Spain, 14004
        • Hospital General Universitario Reina Sofía
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia - PPDS
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Palma de Mallorca, Spain, 07198
        • Hospital Universitario Son Llatzer
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15781
        • Centro de Farmacovigilancia de Galicia
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro de Majadahonda
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Complejo Hospitalario Universitario de Vigo - H. Alvaro Cunqueiro
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
    • Glasgow CITY
      • Glasgow, Glasgow CITY, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital - PPDS
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Hospital
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham the Kirklin Clinic
      • Birmingham, Alabama, United States, 35249
        • IDS Pharmacy at UAB Hospital
      • Birmingham, Alabama, United States, 35294
        • Cardiovascular Clinical Trials Unit
      • Mobile, Alabama, United States, 36608
        • CB Flock Research Corporation
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
      • Chandler, Arizona, United States, 85224
        • Valley Heart Rhythm Specialists, PLLC
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Gilbert, Arizona, United States, 85297-0425
        • Cardiovascular and Stem Cell Consultants
      • Gilbert, Arizona, United States, 85297-0425
        • Cardiovascular Research Clinic
      • Gilbert, Arizona, United States, 85297-0425
        • Dignity Health, Mercy Gilbert Medical Center
      • Tucson, Arizona, United States, 85712
        • Children's Clinic
      • Tucson, Arizona, United States, 85713
        • Banner - Banner University Medical Center South
      • Tucson, Arizona, United States, 85719
        • Banner - University Medical Center Tucson
      • Tucson, Arizona, United States, 85719
        • Banner University Medicine North
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center Tuscon
      • Tucson, Arizona, United States, 85724
        • University of Arizona Sarver Heart Center
    • California
      • Los Angeles, California, United States, 90095
        • Ahmanson Cardiomyopathy Center Cardiovascular Genetics
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • University of Colorado Academic Offices Building
      • Aurora, Colorado, United States, 80045
        • University of Colorado Clinical and Translational Research Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida
      • Tampa, Florida, United States, 33606-3601
        • University of South Florida
      • Tampa, Florida, United States, 33606
        • USF Health
      • Tampa, Florida, United States, 33609
        • Florida Cardiovascular Institute PA
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Centers for Heart Failure Therapy
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Columbus, Georgia, United States, 31904-6877
        • Columbus Cardiology Associates Research - Centricity Research - HyperCore - PPDS
      • Columbus, Georgia, United States, 31904-6877
        • Columbus Cardiology Associates Research - IACT - HyperCore - PPDS
      • Columbus, Georgia, United States, 31904-8946
        • Columbus Regional Research Institute at Talbotton - Centricity Research - HyperCore - PPDS
    • Idaho
      • Boise, Idaho, United States, 83712-6246
        • Saint Luke's Idaho Cardiology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Midland, Michigan, United States, 48670
        • MyMichigan Medical Center Midland
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Washington University Center For Advanced Medicine
      • Saint Louis, Missouri, United States, 63110
        • Washington University Center for Outpatient Health
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School - Doctors Office Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10016
        • NYU School of Medicine / NYU Langone Health
      • New York, New York, United States, 10032
        • Columbia University/Presbyterian Hospital - Vivian & Seymour Milstein Family Heart Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina - PPDS
      • Charleston, South Carolina, United States, 29425-8911
        • Medical University of South Carolina - PPDS
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Stern Cardiovascular Foundation Inc
      • Tullahoma, Tennessee, United States, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Scott and White Heart and Vascular Hospital
      • Dallas, Texas, United States, 75246
        • Baylor Annette C and Harold C Simmons Transplant Institute
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Meriter Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Double-blind Treatment
ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally
400 mg twice daily (BID)
BID
Experimental: Part 2 Open-label Treatment
ARRY-371797 (PF-07265803) tablet orally
400 mg twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Six-Minute Walk Test (6 MWT) at Week 24
Time Frame: Baseline, Week 24
The 6 MWT was an assessment where the distance that a participant could walk on a flat and hard surface in 6 minutes was measured. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional. Study discontinuation & death were incorporated into endpoint definition through ranking in hypothesis testing of treatment difference. Missing data resulting from study discontinuation were imputed using control-based multiple imputation method to estimate treatment effect.
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 6 MWT at Weeks 4 and 12
Time Frame: Baseline, Week 4, Week 12
The 6 MWT was an assessment where the distance that a participant could walk on a flat and hard surface in 6 minutes was measured. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional.
Baseline, Week 4, Week 12
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) and Total Symptom Score (TSS) Domain Scores at Weeks 12 and 24
Time Frame: Baseline, Week 12, Week 24
The KCCQ measured the effects of symptoms, functional (physical) limitations, and psychological distress on an individual's health-related quality of life. It contains 23 items, which assessed the ability to perform activities of daily living, frequency and severity of symptoms, the impact of these symptoms, and health-related quality of life. PL was a single questionnaire with score range of 0 to 100, where higher scores reflected better physical functioning status. TSS included frequency and severity of symptoms, and the impact of these symptoms. TSS scores were transformed to a range of 0 to 100, where higher scores reflected better health status.
Baseline, Week 12, Week 24
Number of Participants With Improvement From Baseline in Patient Global Impression of Severity (PGI-S) Score at Weeks 12 and 24
Time Frame: Week 12, Week 24
PGI-S is a global index that rate the severity of the disease using a 5-point scale. In this outcome the number of participants with improvements in PGI-S the severity of their heart failure symptoms and in the severity of their PL were reported. Measured by the scale of: none, mild, moderate, severe or very severe (listed from better to worse).
Week 12, Week 24
Number of Participants With Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Weeks 12 and 24
Time Frame: Week 12, Week 24
PGI-C is a global index that rate the severity of the disease using a 7-point scale. In this outcome the number participants with improvements in their heart failure symptoms and "in their physical activity limitations?", were reported. 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).
Week 12, Week 24
Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Weeks 4, 12, and 24
Time Frame: Baseline, Week 4, Week 12, Week 24
NT pro-BNP is a cardiac biomarker that is released in the blood in response to changes in the pressure inside of the heart. Levels go up when heart failure develops or gets worse, and levels go down when heart failure is stable or improves. This biomarker helps to measure the changes in the severity of heart failure over time in response to therapy.
Baseline, Week 4, Week 12, Week 24
Composite Time to First Occurrence of All-Cause Mortality or Worsening Heart Failure (WHF)
Time Frame: Maximum up to 212.28 weeks (maximum exposure was 208 weeks)
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). Kaplan-Meier method and cox regression model were used for analysis.
Maximum up to 212.28 weeks (maximum exposure was 208 weeks)
Overall Survival (OS)
Time Frame: From randomization up to death due to any cause or censored date, maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
OS was defined as time from randomization to death due to any cause. Participants who did not have a death date were censored for OS at their last contact date. Kaplan-Meier method and cox regression model were used for analysis.
From randomization up to death due to any cause or censored date, maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants With Treatment Emergent Adverse Events (AEs) and by Severity
Time Frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 30 days after last dose. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all Non-SAEs. Grade >=3 AEs meant severe AEs.
Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants With Laboratory Test Abnormalities
Time Frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Following parameters were analyzed for laboratory examination: hematology (eosinophils, erythrocytes, hemoglobin, hematocrit, granulocytes, leukocytes, lymphocytes, monocytes, platelets, neutrophils, nucleated erythrocytes); blood chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, C-reactive protein, calcium, chloride, creatinine, creatine kinase, epidermal growth factor receptor, follicle stimulating hormone, gamma glutamyl transferase, glucose, magnesium, N-Terminal ProB-type natriuretic peptide, phosphate, potassium, protein, sodium, potassium, thyrotropin, troponin I, troponin T, urate).
Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants According to Categorization of Abnormal Vital Signs
Time Frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, heart rate, and body weight. Vital sign abnormalities criteria included: a) systolic blood pressure (mmHg): decrease (change <= -20, or value <90) and increase (change >=20, or value >140); b) diastolic blood pressure (mmHg): decrease (change <= -15, or value <60) and increase (change >=15, or value >90); c) heart Rate (bpm) decrease: (change <= -15, or value <50) and increase (change >=15, or value >100); d) weight: (kg) decrease (Change <= -7%) and increase (Change > =7%).
Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants According to Categorization of Electrocardiogram (ECG) Data
Time Frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Following parameters were analyzed: heart rate, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, and Fridericia's correction (QTcF) interval. Criteria for notable ECG values were as follows: QT interval (in millisecond [msec]) new (newly occurring post-baseline value) greater than (>) 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; heart rate in bpm new (newly occurring post-baseline value) <60 and >100.
Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants With a New Clinically Significant Ventricular or Atrial Arrhythmias
Time Frame: Baseline, Week 12, Week 24
Arrhythmia assessment: incidence of new and clinically significant ventricular or atrial arrhythmias was assessed by an implantable cardioverter defibrillator (ICD) or CRT defibrillator (CRT-D) applicable device interrogations.
Baseline, Week 12, Week 24

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Actual)

October 13, 2022

Study Completion (Actual)

October 13, 2022

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ARRAY-797-301
  • C4411002 (Other Identifier: Alias Study Number)
  • 2017-004310-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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