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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337674
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : February 2, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 15, 2011
First Posted Date  ICMJE April 19, 2011
Results First Submitted Date  ICMJE October 30, 2015
Results First Posted Date  ICMJE February 2, 2016
Last Update Posted Date December 24, 2018
Actual Study Start Date  ICMJE April 1, 2011
Actual Primary Completion Date November 1, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • 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) ]
  • Change from baseline in systolic blood pressure [ Time Frame: Baseline and Day 1 ]
  • Change from baseline in systolic blood pressure [ Time Frame: Baseline and Day 7 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Steady-state area under the concentration versus time curve [AUC(0-24hr)] for MK-4618 [ Time Frame: Day 7 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)
Official Title  ICMJE A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: Metoprolol
  • Experimental: 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.
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: Metoprolol
  • Experimental: 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.
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: Amlodipine
  • Experimental: 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.
    Interventions:
    • Drug: MK-4618
    • Drug: Placebo for MK-4618
    • Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2011)
24
Actual Study Completion Date  ICMJE November 1, 2011
Actual Primary Completion Date November 1, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01337674
Other Study ID Numbers  ICMJE 4618-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date December 2018

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