Phase 1
Completed N=40
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)
Source: ClinicalTrials.gov NCT01096160 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up — 5; 0; 5; 1 Count of Participants
Summary
This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up |
5; 0; 5; 1; 3; 1 | — |
| PRIMARY Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo |
141.5; 132.6; 148.6; 134.5; 146.7; -5.09 | 0.1194 |
| PRIMARY Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo |
65.89; 69.32; 62.30; 66.10; 62.04 | 0.1161 |
| SECONDARY Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo |
8.81; 7.45; 13.50; 11.89; 18.68 | 0.003 sig |
| SECONDARY Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo |
1.61; 0.74; 1.69; 2.68; 0.54; 1.34 | 0.318 |
| SECONDARY Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo |
-12.3; -12.4 | — |
| SECONDARY Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo |
-17.7; -8.87 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is male with essential hypertension (high blood pressure)
- Participant is in good general health (with the exception of hypertension)
- Participant has a Body Mass Index (BMI) = 150,000 cu/mL at the Screening visit
- Participant has a positive AIx at the Screening visit
Exclusion Criteria
- Participant has a history of stroke, chronic seizure, or major neurological disease
- Participant has a functional disability that can interfere with rising from a seated position to the standing position
- Participant has any history of a bleeding or clotting disorder
- Participant has a history of cancer
- Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication
- Participant consumes excessive amounts of alcohol or caffeinated beverages daily
Data sourced from ClinicalTrials.gov (NCT01096160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.