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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01337674
First received: April 15, 2011
Last updated: December 9, 2011
Last verified: December 2011

April 15, 2011
December 9, 2011
April 2011
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01337674 on ClinicalTrials.gov Archive Site
Steady-state area under the concentration versus time curve [AUC(0-24hr)] for MK-4618 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010 AM1)
A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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
  • Drug: amlodipine
    Previously prescribed daily dose of open-label amlodipine for the duration of the study
    Other Name: Norvasc
  • Experimental: Panel A: MK-4618 then Placebo
    MK-4618 and metoprolol in Period 1, followed by placebo and metoprolol in Period 2
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: metoprolol
  • Experimental: Panel A: Placebo then MK-4618
    Placebo and metoprolol in Period 1, followed by MK-4618 and metoprolol in Period 2
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: metoprolol
  • Experimental: Panel B: MK-4618 then Placebo
    MK-4618 and amlodipine in Period 1, followed by placebo and amlodipine in Period 2
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: amlodipine
  • Experimental: Panel B: Placebo then MK-4618
    Placebo and amlodipine in Period 1, followed by MK-4618 and amlodipine in Period 2
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01337674
MK-4618-010
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP