Clinical trial NCT01337674: Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)
Official title: A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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 \<150 and \>95 mmHg and a diastolic blood pressure \<95 and \>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

Primary outcomes:
measure: Percentage of Participants With a Clinical or Laboratory Adverse Experience
timeFrame: Up to 42 days
measure: Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A
timeFrame: Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7
measure: Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B
timeFrame: Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7
Secondary outcomes:
measure: Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618
timeFrame: Predose and up to 24 hours postdose on Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: