Adults 18 to 60, male only, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Report 1 or More Adverse Events (AEs)- Healthy ParticipantsPrimary· up to 7 weeks
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. Adverse events were summarized by dose taken at the time of the event.
Group
Value
95% CI
0.5 mg MK-8892-Healthy
50.0
1.0 mg MK-8892-Healthy
66.7
2.0 mg MK-8892-Healthy (Pooled)
50.0
4.0 mg MK-8892-Healthy
100.0
6.0 mg MK-8892-Healthy
100.0
9.0 mg MK-8892-Healthy
83.3
12.0 mg MK-8892-Healthy
100.0
14.0 mg MK-8892-Healthy
100.0
Placebo-Healthy
43.8
Percentage of Participants Who Were Discontinued From the Study Due to an AE- Healthy ParticipantsPrimary· up to 7 weeks
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that were discontinued from the study due to an AE was summarized. Adverse events were summarized by dose taken at the time of the event.
Group
Value
95% CI
0.5 mg MK-8892-Healthy
0.0
1.0 mg MK-8892-Healthy
0.0
2.0 mg MK-8892-Healthy (Pooled)
0.0
4.0 mg MK-8892-Healthy
0.0
6.0 mg MK-8892-Healthy
0.0
9.0 mg MK-8892-Healthy
0.0
12.0 mg MK-8892-Healthy
0.0
14.0 mg MK-8892-Healthy
0.0
Placebo-Healthy
0.0
Change in 24-hour Time-weighted Average (TWA0-24hr) for Central Diastolic Blood Pressure (cDBP)- Healthy ParticipantsPrimary· Predose (baseline) and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period of Each Panel)
Central diastolic blood pressure measurements were obtained at predose and at 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose via applanation tonometry of the radial artery. The average central diastolic blood pressure over the 24-hour monitoring period was calculated for each dose of each panel by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Healthy
-1.83
± 1.71
1.0 mg MK-8892-Healthy
-2.27
± 1.69
2.0 mg MK-8892-Healthy
-4.21
± 1.70
4.0 mg MK-8892-Healthy
-4.25
± 1.71
6.0 mg MK-8892-Healthy
-6.22
± 1.70
9.0 mg MK-8892-Healthy
-6.64
± 1.69
12.0 mg MK-8892-Healthy
-6.94
± 1.69
14.0 mg MK-8892-Healthy
-8.89
± 1.70
Placebo-Healthy
-1.33
± 1.26
Percentage of Participants Who Report 1 or More Adverse Events (AEs) - Hypertensive ParticipantsPrimary· up to 7 weeks
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. Adverse events were summarized by dose taken at the time of the event.
Group
Value
95% CI
0.5 mg MK-8892-Hypertensive
50.0
1.0 mg MK-8892-Hypertensive
33.3
2.0 mg MK-8892-Hypertensive
66.7
6.0 mg MK-8892-Hypertensive
77.8
Placebo-Hypertensive
75.0
Percentage of Participants Who Were Discontinued From the Due to an AE - Hypertensive ParticipantsPrimary· up to 7 weeks
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that were discontinued from the study due to an AE was summarized. Adverse events were summarized by dose taken at the time of the event.
Group
Value
95% CI
0.5 mg MK-8892-Hypertensive
0.0
1.0 mg MK-8892-Hypertensive
0.0
2.0 mg MK-8892-Hypertensive
0.0
6.0 mg MK-8892-Hypertensive
0.0
Placebo-Hypertensive
0.0
Change in 24-hour Time-weighted Average (TWA0-24hr) for Central Diastolic Blood Pressure (cDBP) - Hypertensive ParticipantsPrimary· Predose (baseline) and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period)
Central diastolic blood pressure measurements were obtained at predose and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose via applanation tonometry of the radial artery. The average central diastolic blood pressure over the 24-hour monitoring period was calculated for each dose of each panel by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Hypertensive
-3.56
± 1.87
1.0 mg MK-8892-Hypertensive
-4.76
± 1.85
2.0 mg MK-8892-Hypertensive
-7.55
± 1.85
6.0 mg MK-8892-Hypertensive
-7.86
± 1.59
Placebo-Hypertensive
-1.22
± 1.67
Change in TWA0-24hrs for Peripheral Diastolic Blood Pressure (pDBP) - Healthy ParticipantsSecondary· Predose and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period of Each Panel)
Peripheral diastolic blood pressure was measured using a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Healthy
-4.34
± 1.73
1.0 mg MK-8892-Healthy
-2.43
± 0.83
2.0 mg MK-8892-Healthy
-3.69
± 1.10
4.0 mg MK-8892-Healthy
-4.50
± 1.49
6.0 mg MK-8892-Healthy
-6.56
± 1.06
9.0 mg MK-8892-Healthy
-7.04
± 0.99
12.0 mg MK-8892-Healthy
-7.35
± 0.71
14.0 mg MK-8892-Healthy
-9.89
± 1.68
Placebo-Healthy
-1.67
± 0.82
Change in TWA0-24hrs for Heart Rate (HR) - Healthy ParticipantsSecondary· Predose (baseline) and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose (for each Dosing Period of Each Panel)
Heart rate was measured predose and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose by a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Healthy
0.46
± 1.36
1.0 mg MK-8892-Healthy
5.55
± 1.32
2.0 mg MK-8892-Healthy
4.71
± 1.42
4.0 mg MK-8892-Healthy
7.44
± 1.93
6.0 mg MK-8892-Healthy
9.29
± 2.22
9.0 mg MK-8892-Healthy
8.85
± 1.93
12.0 mg MK-8892-Healthy
10.34
± 1.09
14.0 mg MK-8892-Healthy
16.29
± 2.21
Placebo-Healthy
2.23
± 1.11
Change in TWA0-24hr for Augmentation Index (AIx) - Healthy ParticipantsSecondary· Predose (baseline) and 2, 4, 12, and 24 hours postdose (for each Dosing Period of Each Panel)
AIx was measured by applanation tonometry of the radial artery. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours.
Group
Value
95% CI
0.5 mg MK-8892-Healthy
-1.73
± 2.30
1.0 mg MK-8892-Healthy
-2.31
± 2.32
2.0 mg MK-8892-Healthy
-2.82
± 2.31
4.0 mg MK-8892-Healthy
-0.26
± 2.38
6.0 mg MK-8892-Healthy
-4.23
± 2.29
9.0 mg MK-8892-Healthy
-3.85
± 2.31
12.0 mg MK-8892-Healthy
-1.84
± 2.30
14.0 mg MK-8892-Healthy
-4.81
± 2.32
Placebo-Healthy
-0.07
± 2.06
Change in TWA0-24hrs for Peripheral Diastolic Blood Pressure (pDBP) - Hypertensive ParticipantsSecondary· Predose (baseline) and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period of Each Panel)
Peripheral blood pressure assessments were obtained at predose and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose by using a validated automatic measuring device. Peripheral diastolic blood pressure was measured a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. Negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Hypertensive
-3.40
± 1.13
1.0 mg MK-8892-Hypertensive
-4.17
± 1.63
2.0 mg MK-8892-Hypertensive
-7.29
± 1.40
6.0 mg MK-8892-Hypertensive
-9.16
± 1.43
Placebo-Hypertensive
-0.87
± 1.40
Change in TWA0-24hrs for Heart Rate (HR) - Hypertensive ParticipantsSecondary· Predose and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose (for each Dosing Period of Each Panel)
Heart rate was measured predose and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose by a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. Negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Hypertensive
-0.92
± 1.59
1.0 mg MK-8892-Hypertensive
-0.74
± 1.88
2.0 mg MK-8892-Hypertensive
0.87
± 1.92
6.0 mg MK-8892-Hypertensive
7.68
± 1.51
Placebo-Hypertensive
-1.46
± 1.62
TWA0-24hr for Augmentation Index (AIx) - Hypertensive ParticipantsSecondary· Predose to 24 hours Postdose (for each Dosing Period of Each Panel)
AIx was measured by applanation tonometry of the radial artery. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. Negative number indicates a decrease.
Group
Value
95% CI
0.5 mg MK-8892-Hypertensive
-2.30
± 2.01
1.0 mg MK-8892-Hypertensive
-2.57
± 2.01
2.0 mg MK-8892-Hypertensive
-3.94
± 2.01
6.0 mg MK-8892-Hypertensive
-5.43
± 1.80
Placebo-Hypertensive
-1.65
± 1.86
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 7 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate safety, tolerability and effects on central diastolic blood pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and in male participants with mild-to-moderate hypertension (Panel C).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 22 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01798849.