Phase 1
Completed N=26
Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)
Source: ClinicalTrials.gov NCT01337674 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With a Clinical or Laboratory Adverse Experience — 33.3; 53.8; 41.7; 61.5 Percentage of participants
Summary
This study will evaluate the safety and tolerability of MK-4618 when coadministered with antihypertensive agents and will evaluate changes in blood pressure following co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of the study is that MK-4618 does not result in a clinically meaningful change in systolic blood pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Clinical or Laboratory Adverse Experience |
33.3; 53.8; 41.7; 61.5 | — |
| PRIMARY Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A |
16.03; 17.25; 14.38; 12.10; 14.79; 13.14 | — |
| PRIMARY Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B |
14.69; 12.74; 10.52; 16.43; 6.50; 12.75 | — |
| SECONDARY Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618 |
2.60; 4.60 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female not of childbearing potential
- Not a nursing mother
- Must be on stable dose of a beta blocker (Panel A only) or amlodipine (Panel B only) for the treatment of hypertension for at least 6 weeks prior to enrollment. Must take the designated daily dose of metoprolol or amlodipine for the duration of the study
- In good health other than hypertension
- Nonsmoker
- Participant has a resting systolic blood pressure 95 mmHg and a diastolic blood pressure 75 mmHg at prestudy clinical evaluation
Exclusion Criteria
- Any illness that might confound the results of the study or pose a risk by participation
- History of orthostatic hypotension (decrease in blood pressure upon standing accompanied by symptoms of lightheadedness or dizziness)
- History of cancer, excepting certain skin or cervical cancers or cancers that were treated successfully 10 or more years prior to screening
- Condition for which there is a warning, contraindication, or precaution against the use of extended release metoprolol (Panel A) or amlodipine (Panel B)
- Consumes excessive amounts of alcohol or caffeine daily
- Has multiple and/or severe allergies (including latex allergy) or has had an anaphylactic reaction or significant intolerance to drugs or food
- Uses illicit drugs or has a history of drug abuse
Data sourced from ClinicalTrials.gov (NCT01337674). 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.