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

NCT ID: NCT01337674

Last Updated: 2018-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-01

Study Completion Date

2011-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel A: MK-4618 + Met → PBO + Met

Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.

Group Type EXPERIMENTAL

MK-4618

Intervention Type DRUG

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

Placebo for MK-4618

Intervention Type DRUG

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

Metoprolol

Intervention Type DRUG

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

Panel A: PBO + Met → MK-4618 + Met

Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.

Group Type EXPERIMENTAL

MK-4618

Intervention Type DRUG

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

Placebo for MK-4618

Intervention Type DRUG

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

Metoprolol

Intervention Type DRUG

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

Panel B: MK-4618 + Amlo → PBO + Amlo

Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.

Group Type EXPERIMENTAL

MK-4618

Intervention Type DRUG

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

Placebo for MK-4618

Intervention Type DRUG

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

Amlodipine

Intervention Type DRUG

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

Panel B: PBO + Amlo → MK-4618 + Amlo

Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.

Group Type EXPERIMENTAL

MK-4618

Intervention Type DRUG

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

Placebo for MK-4618

Intervention Type DRUG

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

Amlodipine

Intervention Type DRUG

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

Interventions

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MK-4618

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

Intervention Type DRUG

Placebo for MK-4618

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

Intervention Type DRUG

Metoprolol

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

Intervention Type DRUG

Amlodipine

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

Intervention Type DRUG

Other Intervention Names

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Toprol-XL Norvasc

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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United States

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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4618-010

Identifier Type: -

Identifier Source: org_study_id