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

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 22, 2015
Last verified: December 2015
Results First Received: October 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: MK-4618
Drug: Placebo for MK-4618
Drug: Metoprolol
Drug: Amlodipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    Panel A: MK-4618 + Met → PBO + Met     Panel A: PBO + Met → MK-4618 + Met     Panel B: MK-4618 + Amlo → PBO + Amlo     Panel B: PBO + Amlo → MK-4618 + Amlo  
STARTED     6     7 [1]   6     7 [1]
COMPLETED     6     6     6     6  
NOT COMPLETED     0     1     0     1  
Adverse Event                 0                 1                 0                 0  
Discontinued due to blood draws                 0                 0                 0                 1  
[1] The discontinued participant was replaced

Period 2:   Two-week Washout Period
    Panel A: MK-4618 + Met → PBO + Met     Panel A: PBO + Met → MK-4618 + Met     Panel B: MK-4618 + Amlo → PBO + Amlo     Panel B: PBO + Amlo → MK-4618 + Amlo  
STARTED     6     6     6     6  
COMPLETED     6     6     6     6  
NOT COMPLETED     0     0     0     0  

Period 3:   Treatment Period 2
    Panel A: MK-4618 + Met → PBO + Met     Panel A: PBO + Met → MK-4618 + Met     Panel B: MK-4618 + Amlo → PBO + Amlo     Panel B: PBO + Amlo → MK-4618 + Amlo  
STARTED     6     6     6     6  
COMPLETED     6     6     5     6  
NOT COMPLETED     0     0     1     0  
Withdrawal by Subject                 0                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Panel A Participants Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
Panel B Participants Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
Total Total of all reporting groups

Baseline Measures
    Panel A Participants     Panel B Participants     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: Years]
Mean (Full Range)
  53.8  
  (42 to 68)  
  55.2  
  (41 to 77)  
  54.5  
  (41 to 77)  
Gender  
[units: Participants]
     
Female     4     8     12  
Male     9     5     14  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Clinical or Laboratory Adverse Experience   [ Time Frame: Up to 42 days ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme, Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01337674     History of Changes
Other Study ID Numbers: 4618-010
Study First Received: April 15, 2011
Results First Received: October 30, 2015
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration