Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01337674
First received: April 15, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: MK-4618
Drug: Placebo for MK-4618
Drug: metoprolol
Drug: amlodipine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants who experience clinical or laboratory adverse events [ Time Frame: Day 1 to 14 days following the last dose of study drug (approximately 60 days) ] [ Designated as safety issue: Yes ]
  • Change from baseline in systolic blood pressure [ Time Frame: Baseline and Day 1 ] [ Designated as safety issue: No ]
  • Change from baseline in systolic blood pressure [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Steady-state area under the concentration versus time curve [AUC(0-24hr)] for MK-4618 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A: MK-4618 then Placebo
MK-4618 and metoprolol in Period 1, followed by placebo and metoprolol in Period 2
Drug: MK-4618
Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7
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
Drug: metoprolol
Previously prescribed daily dose of open-label metoprolol for the duration of the study
Other Name: Toprol-XL
Experimental: Panel A: Placebo then MK-4618
Placebo and metoprolol in Period 1, followed by MK-4618 and metoprolol in Period 2
Drug: MK-4618
Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7
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
Drug: metoprolol
Previously prescribed daily dose of open-label metoprolol for the duration of the study
Other Name: Toprol-XL
Experimental: Panel B: MK-4618 then Placebo
MK-4618 and amlodipine in Period 1, followed by placebo and amlodipine in Period 2
Drug: MK-4618
Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7
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
Drug: amlodipine
Previously prescribed daily dose of open-label amlodipine for the duration of the study
Other Name: Norvasc
Experimental: Panel B: Placebo then MK-4618
Placebo and amlodipine in Period 1, followed by MK-4618 and amlodipine in Period 2
Drug: MK-4618
Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7
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
Drug: amlodipine
Previously prescribed daily dose of open-label amlodipine for the duration of the study
Other Name: Norvasc

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 of <160 mmHg and a diastolic blood pressure <100 mmHg prior to randomization

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01337674     History of Changes
Other Study ID Numbers: MK-4618-010
Study First Received: April 15, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Metoprolol
Amlodipine
Metoprolol succinate
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents

ClinicalTrials.gov processed this record on August 01, 2014