Trial · NCT02351856
A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
NCT02351856, Phase 2, Completed, Pfizer; results first posted 2022-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy. Trials, record NCT02351856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02351856
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
- NCT number
- NCT02351856
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- LMNA-Related Dilated Cardiomyopathy
- Interventions
- ARRY-371797, p38 inhibitor, oral
- First posted
- 2015-01-30
- Last updated
- 2022-03-31
- Results first posted
- 2022-03-31
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent AEs were events between baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Primary | Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) | In this outcome measure, number of participants with baseline laboratory hematology values as per National Cancer Institute Common Terminology Criteria (NCI-CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes/shift to the worst CTC grades post baseline were presented. Shift data have been reported for hematology parameters: hemoglobin (g/L), platelets (10\^9/L), leukocytes (10\^9/L), neutrophils (10\^9/L), lymphocytes (10\^9/L) and eosinophils (10\^9/L). Baseline was defined as last non-missing value before the initial administration of study treatment in parent study and worst post-baseline value defined as worst value between first dose of study drug up to the maximum of 282 weeks. Only those categories in which at least 1 participant had data were reported. |
| Primary | Number of Participants With Change From Baseline Value in Clinical Laboratory Chemistry Test Results to Worst Value | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) | In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTC grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes/shift to the worst CTC grades post baseline were presented. Shift data have been reported for laboratory parameters: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, international unit per liter (IU/L), albumin, bilirubin, urea nitrogen, calcium, creatinine, glucose, magnesium, protein and phosphate grams per deciliter (g/dL), potassium and sodium, millimol per liter (mmol/L). Baseline was defined as last non-missing value before the initial administration of study treatment in parent study and worst post-baseline value defined as worst value between first dose of study drug up to the maximum of 282 weeks. Only those categories in which at least 1 participant had data were reported. |
| Primary | Number of Participants With Abnormal Physical Examination Findings | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Physical examination included the assessment of skin, head, ears, eyes, nose, throat, cardiovascular system, abdomen and lungs. Abnormality in physical examination were based on investigator's discretion. |
| Primary | Number of Participants With Abnormalities in Vital Signs | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Following vital signs parameters were analyzed using prespecified range of results for signs of clinical significance: systolic blood pressure in millimeters of mercury (mmHg): \<90 mmHg and ≥160 mmHg, diastolic blood pressure: \<60 mmHg and ≥100 mmHg, heart rate in beats per minute (bpm): \<40bpm and \>120 bpm, temperature in degree Celsius (C): \<36.1 and \> 37.2 degree C. |
| Primary | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Following ECG parameters were analyzed using prespecified range of results for signs of clinical significance: heart rate: \<40bpm and \>120 bpm; QT/QTcF (QT interval corrected using Fridericia's formula) criteria: QT interval \>500 ms; QTcF interval \>450 ms; or change from baseline in QTcF \>30 ms. |
| Secondary | Change From Baseline in Six Minute Walk Test (6MWT) Distance at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | 6MWT was the distance that a participant could quickly walk on a flat, hard surface in a period of 6 minutes. Participants were asked to walk a set course of 30 meters for 6 minutes (timed), and the distance walked (in meters) was recorded. Change from baseline in 6MWT distance at specified time points were reported. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. |
| Secondary | Change From Baseline in Left Ventricular End Systolic Index (LVESVI) and Left Ventricular End Diastolic Volume Index (LVEDVI) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | LVESVI and LVEDVI were echocardiographic assessment of left ventricular remodeling. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. |
| Secondary | Change From Baseline in Left Ventricular Mass (LVM) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | LVM is the weight of the left ventricle in grams estimated by echocardiography. For this outcome measure, Baseline is the pre-dose baseline of parent study. |
| Secondary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | LVEF was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here, Number Analyzed signifies participants evaluable for specific parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline Value in Clinical Laboratory Chemistry Test Results to Worst Value | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here, Number Analyzed signifies participants evaluable for specific parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Physical Examination Findings | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Vital Signs | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Six Minute Walk Test (6MWT) Distance at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | Efficacy analysis set included participants who had at least 1 post-baseline efficacy evaluation. Here, Number Analyzed signifies participants evaluable for specific time point. | Meters | MEAN |
| SECONDARY | Change From Baseline in Left Ventricular End Systolic Index (LVESVI) and Left Ventricular End Diastolic Volume Index (LVEDVI) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | Efficacy analysis set included participants who had at least 1 post-baseline efficacy evaluation. Here, Number Analyzed signifies participants evaluable for specific time point. | Milliliter per meter square | MEAN |
| SECONDARY | Change From Baseline in Left Ventricular Mass (LVM) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, Number Analyzed signifies participants evaluable for specific time point. | Grams | MEAN |
| SECONDARY | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, Number Analyzed signifies participants evaluable for specific time point. | Percentage of EDV | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group277
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | ARRY-371797 | SAEs | 6 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | ARRY-371797 | TEAEs | 8 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Hemoglobin: grade 0 (baseline grade) to post baseline grade 1 | 3 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Hemoglobin: grade 0 (baseline grade) to post baseline grade 2 | 4 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Hemoglobin: grade 0 (baseline grade) to post baseline grade 3 | 1 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Platelets: grade 0 (baseline grade) to post baseline grade 0 | 6 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Platelets: grade 0 (baseline grade) to post baseline grade 1 | 1 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Platelets: grade 1 (baseline grade) to post baseline grade 3 | 1 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Leukocytes: grade 0 (baseline grade) to post baseline grade 0 | 6 | Participants | |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | ARRY-371797 | Leukocytes: grade 1 (baseline grade) to post baseline grade 1 | 2 | Participants |
1 to 10 of 277Source ClinicalTrials.gov
See all 277 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARRY-371797 | 8 | |
| Overall Study | COMPLETED | ARRY-371797 | 0 | |
| Overall Study | NOT COMPLETED | ARRY-371797 | 8 |
Source ClinicalTrials.gov
Adverse events61
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | ARRY-371797 | 1 | 8 | |
| other | Cardiac failure | Cardiac disorders | ARRY-371797 | 1 | 8 | |
| other | Congestive cardiomyopathy | Cardiac disorders | ARRY-371797 | 1 | 8 | |
| other | Ventricular tachycardia | Cardiac disorders | ARRY-371797 | 3 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | ARRY-371797 | 1 | 8 | |
| other | Ascites | Gastrointestinal disorders | ARRY-371797 | 1 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | ARRY-371797 | 2 | 8 | |
| other | Gastritis | Gastrointestinal disorders | ARRY-371797 | 1 | 8 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | ARRY-371797 | 1 | 8 | |
| other | Haemorrhoids | Gastrointestinal disorders | ARRY-371797 | 1 | 8 |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARRY-371797 | 0 | 8 |
| Total, other adverse events | ARRY-371797 | 7 | 8 |
| Total, serious adverse events | ARRY-371797 | 6 | 8 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02351856
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