Trial · NCT02861534

A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)

NCT02861534, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2020-06-29

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001). Trials, record NCT02861534. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02861534

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
NCT number: NCT02861534
Status: Completed
Phases: Phase 3
Enrollment: 5,050 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction
Interventions: Vericiguat, Placebo for vericiguat
First posted: 2016-08-10
Last updated: 2021-11-15
Other registries' IDs: eudract:2016-000671-25
Results first posted: 2020-06-29

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Time to First Occurrence of Composite Endpoint of CV Death or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization or CV death event at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A clinical events committee (CEC) reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Secondary	Time to the First Occurrence of CV Death	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Time to First Occurrence of CV Death was analyzed using a one-sided stratified log-rank test. Randomized participants without a CV death at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Secondary	Time to the First Occurrence of HF Hospitalization	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Time to the First Occurrence of HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Secondary	Time to Total HF Hospitalizations (Including First and Recurrent Events)	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Time to Total HF Hospitalizations (including first and recurring) was analyzed using an Andersen-Gill model. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years of follow-up) is provided.
Secondary	Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event or HF hospitalization at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Secondary	Time to All-Cause Mortality	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Time to All-Cause Mortality was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results: the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Secondary	Number of Participants Who Experienced One or More Adverse Events	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Secondary	Number of Participants Who Discontinued Treatment Due to an Adverse Event	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Secondary	Percentage of Participants Who Experienced Symptomatic Hypotension	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Study participants were monitored for symptomatic hypotension, an event of clinical interest, and results were reported.
Secondary	Percentage of Participants Who Experienced Syncope	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	Study participants were monitored for syncope, an event of clinical interest, and results were reported.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Time to the First Occurrence of CV Death	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants	Parts w/ event per 100 part-yrs at risk	NUMBER
SECONDARY	Time to the First Occurrence of HF Hospitalization	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants	Parts w/ event per 100 part-yrs at risk	NUMBER
PRIMARY	Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants	Parts w/ event per 100 part-yrs at risk	NUMBER
SECONDARY	Time to Total HF Hospitalizations (Including First and Recurrent Events)	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants	Parts w/ event per 100 part-yrs	NUMBER
SECONDARY	Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants	Parts w/ event per 100 part-yrs at risk	NUMBER
SECONDARY	Time to All-Cause Mortality	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants	Parts w/ event per 100 part-yrs at risk	NUMBER
SECONDARY	Number of Participants Who Experienced One or More Adverse Events	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants who received at least 1 dose of study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Discontinued Treatment Due to an Adverse Event	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants who received at least 1 dose of study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Who Experienced Symptomatic Hypotension	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants who received at least 1 dose of study treatment	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Experienced Syncope	Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)	All randomized participants who received at least 1 dose of study treatment	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to the First Occurrence of CV Death	Vericiguat	12.9		Parts w/ event per 100 part-yrs at risk
Time to the First Occurrence of CV Death	Placebo	13.9		Parts w/ event per 100 part-yrs at risk
Time to the First Occurrence of HF Hospitalization	Vericiguat	25.9		Parts w/ event per 100 part-yrs at risk
Time to the First Occurrence of HF Hospitalization	Placebo	29.1		Parts w/ event per 100 part-yrs at risk
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization	Vericiguat	33.6	41.5 to 46.4	Parts w/ event per 100 part-yrs at risk
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization	Placebo	37.8	44.4 to 49.4	Parts w/ event per 100 part-yrs at risk
Time to Total HF Hospitalizations (Including First and Recurrent Events)	Vericiguat	38.3		Parts w/ event per 100 part-yrs
Time to Total HF Hospitalizations (Including First and Recurrent Events)	Placebo	42.4		Parts w/ event per 100 part-yrs
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization	Vericiguat	35.9		Parts w/ event per 100 part-yrs at risk
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization	Placebo	40.1		Parts w/ event per 100 part-yrs at risk

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vericiguat	2,526
Overall Study	STARTED	Placebo	2,524
Overall Study	Treated	Vericiguat	2,519
Overall Study	Treated	Placebo	2,515
Overall Study	COMPLETED	Vericiguat	1,952
Overall Study	COMPLETED	Placebo	1,937
Overall Study	NOT COMPLETED	Vericiguat	574
Overall Study	NOT COMPLETED	Placebo	587

Source ClinicalTrials.gov

Adverse events1,582

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	Anaemia	Blood and lymphatic system disorders	Vericiguat	165	2,519	181
other	Anaemia	Blood and lymphatic system disorders	Placebo	134	2,515	139
other	Cardiac failure	Cardiac disorders	Vericiguat	160	2,519	219
other	Cardiac failure	Cardiac disorders	Placebo	157	2,515	221
other	Diarrhoea	Gastrointestinal disorders	Vericiguat	127	2,519	141
other	Diarrhoea	Gastrointestinal disorders	Placebo	120	2,515	136
other	Nasopharyngitis	Infections and infestations	Vericiguat	126	2,519	153
other	Nasopharyngitis	Infections and infestations	Placebo	131	2,515	163
other	Hyperkalaemia	Metabolism and nutrition disorders	Vericiguat	112	2,519	124
other	Hyperkalaemia	Metabolism and nutrition disorders	Placebo	138	2,515	167

1 to 10 of 1,582Source ClinicalTrials.gov

See all 1,582 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vericiguat	553	2,526
Total, all-cause mortality	Placebo	561	2,524
Total, other adverse events	Vericiguat	958	2,519
Total, other adverse events	Placebo	925	2,515
Total, serious adverse events	Vericiguat	852	2,519
Total, serious adverse events	Placebo	897	2,515

Source ClinicalTrials.gov

Papers22

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29032136	DERIVED	PubMed
31820546	RESULT	PubMed
32222134	DERIVED	PubMed
33039447	DERIVED	PubMed
33185650	DERIVED	PubMed
34216757	DERIVED	PubMed
34407626	DERIVED	PubMed
34432985	DERIVED	PubMed
34743540	DERIVED	PubMed
35656822	DERIVED	PubMed

1 to 10 of 22

See all 22 papers

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vericiguat vs Placebo: Number of Participants Who Experienced One or More Adverse Events	Trial comparisons
Vericiguat vs Placebo: Number of Participants Who Discontinued Treatment Due to an Adverse Event	Trial comparisons
Vericiguat vs Placebo: deaths from any cause	Trial comparisons
Vericiguat vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02861534

GET https://conductscience.org/api/trials/v1/NCT02861534/events?page=2

API reference For AI assistants