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Completed

NCT Number: NCT01337674

Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-4618

Drug

Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7

Placebo for MK-4618

Drug

Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7

metoprolol

Drug

Previously prescribed daily dose of open-label metoprolol for the duration of the study

Other names: Toprol-XL

Amlodipine

Drug

Previously prescribed daily dose of open-label amlodipine for the duration of the study

Other names: Norvasc

Primary outcomes

  1. Percentage of Participants With a Clinical or Laboratory Adverse Experience

    Time frame: Up to 42 days

    An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.

  2. Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A

    Time frame: Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7

    Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.

  3. Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B

    Time frame: Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7

    Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.

Secondary outcomes

  1. Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618

    Time frame: Predose and up to 24 hours postdose on Day 7

    Blood samples were collected on Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose for the determination of plasma MK-4618 concentration. The hypothesis for this outcome is that the steady-state AUC0-24hr for MK-4618 is >=0.47 uM*hr.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 19, 2011
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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