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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01337674
First received: April 15, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
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 June 18, 2013