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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Argentina
      • 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
        • Fundación favaloro para la Docencia e Investigación Médica
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000 PBJ
        • Instituto Caici
      • Rosario, Santa FE, Argentina, S2000KDS
        • Hospital Provincial del Centenario
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
    • Oost-vlaanderen
      • Aalst, Oost-vlaanderen, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis
  • Canada
    • 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
  • Italy
      • 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
  • Mexico
      • 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
  • Netherlands
    • Noord-holland
      • Amsterdam, Noord-holland, Netherlands, 1105 AZ
        • Amsterdam UMC, Location Academic Medical Center
  • Norway
      • Hamar, Norway, 2318
        • Sykehuset Innlandet HF Hamar
      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet
  • Spain
      • 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 Sofia
      • 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
  • United Kingdom
      • 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
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Double-blind Treatment
ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally
Drug: ARRY-371797 (PF-07265803)
400 mg twice daily (BID)
Other: Placebo
BID
Experimental: Part 2 Open-label Treatment
ARRY-371797 (PF-07265803) tablet orally
Drug: ARRY-371797 (PF-07265803)
400 mg twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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