A Phase 1 interventional study of MK-8892 in Pulmonary Hypertension and Left Heart Disease, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
This study will assess multiple doses of MK-8892 administered to participants with pulmonary hypertension "out of proportion" (PHOOP) and heart failure with reduced left ventricular ejection fraction (rEF). It is hypothesized that generally safe and well tolerated multiple doses of MK-8892 will achieve a true reduction from baseline in pulmonary vascular resistance (PVR) greater than 12%.
Sixteen participants with PHOOP/rEF were to receive multiple doses of MK-8892 titrated to the highest tolerated dose for each participant (up to 4 mg daily), and to undergo evaluation for safety and systemic hemodynamics and cardiac function. Only 4 participants were enrolled and completed the study due to a strategic business decision by the sponsor to terminate the clinical conduct of all MK-8892 ongoing trials including this trial.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 4 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Starting dose of 1 mg daily (oral); the dose may be titrated up on the 8th, 15th, and 22nd day of treatment to 2 mg, 3 mg, or 4 mg, respectively, for the duration of the study (28 days) as tolerated. For participants who reach one or more of the down-dosing criteria, there is an opportunity to decrease the dose back to a previously well-tolerated dose level, or to ½ of the starting dose.
Drug: MK-8892
Percentage Change From Baseline in Pulmonary Vascular Resistance (PVR)
Pulmonary vascular resistance (PVR) is the general pressure which the right ventricle must counteract to pump blood through the lungs. PVR was measured by right heart catheterization performed prior to dosing at baseline (Day 1) and 4 hours postdose on Day 28. Percentage change in PVR from baseline at Day 28 was calculated as \[(Baseline-Day 28)/Baseline\]. Standard deviation is reported as a percentage.
Time frame: Baseline and Day 28
Number of Participants Who Experienced an Adverse Event
An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.
Time frame: Up to 42 days
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.
Time frame: Up to 28 days
| Milestone | MK-8892 |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
Pulmonary vascular resistance (PVR) is the general pressure which the right ventricle must counteract to pump blood through the lungs. PVR was measured by right heart catheterization performed prior to dosing at baseline (Day 1) and 4 hours postdose on Day 28. Percentage change in PVR from baseline at Day 28 was calculated as \[(Baseline-Day 28)/Baseline\]. Standard deviation is reported as a percentage.
| Percentage change | MK-8892 |
|---|---|
| Percentage Change From Baseline in Pulmonary Vascular Resistance (PVR) | -51 ± 199 |
An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.
| Participants | MK-8892 |
|---|---|
| Number of Participants Who Experienced an Adverse Event | 0 |
An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.
| Participants | MK-8892 |
|---|---|
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 |
Collected over Up to 42 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-8892 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(Years) | MK-8892 |
|---|---|
| Mean | 60 ± 5.6 |
| Sex: Female, Male(Participants) | MK-8892 |
|---|---|
| Female | 1 |
| Male | 3 |
No study locations are listed for this record.
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC