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A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8150 (MK-8150-002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01656408
First received: July 12, 2012
Last updated: March 29, 2016
Last verified: March 2016
Results First Received: March 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Hypertension
Isolated Systolic Hypertension
Interventions: Drug: MK-8150
Drug: Placebo for MK-8150

  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
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Reporting Groups
  Description
Panel A – Participants With Mild to Moderate Hypertension 6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel B – Participants With Mild to Moderate Hypertension 6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel C – Participants With Mild to Moderate Hypertension 6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel D – Participants With Mild to Moderate Hypertension 5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel E – Elderly Participants With Mild/Moderate Hypertension 6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
Panel F – Elderly Participants With Mild/Moderate Hypertension 6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
Panel G – Healthy Participants 8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
Panel H – Participants With Resistant Hypertension In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
Panel I – Participants With Mild to Moderate Hypertension 12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
Panel J – Participants With Mild to Moderate Hypertension 12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria

Participant Flow:   Overall Study
    Panel A – Participants With Mild to Moderate Hypertension     Panel B – Participants With Mild to Moderate Hypertension     Panel C – Participants With Mild to Moderate Hypertension     Panel D – Participants With Mild to Moderate Hypertension     Panel E – Elderly Participants With Mild/Moderate Hypertension     Panel F – Elderly Participants With Mild/Moderate Hypertension     Panel G – Healthy Participants     Panel H – Participants With Resistant Hypertension     Panel I – Participants With Mild to Moderate Hypertension     Panel J – Participants With Mild to Moderate Hypertension  
STARTED     8     8     8     7     9     9     10     8     18     18  
COMPLETED     7     8     6     7     8     7     9     7     16     15  
NOT COMPLETED     1     0     2     0     1     2     1     1     2     3  
Adverse Event                 0                 0                 1                 0                 0                 1                 1                 0                 1                 0  
Physician Decision                 1                 0                 1                 0                 1                 1                 0                 1                 1                 3  



  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 With Mild to Moderate Hypertension 6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel B – Participants With Mild to Moderate Hypertension 6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel C – Participants With Mild to Moderate Hypertension 6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel D – Participants With Mild to Moderate Hypertension 5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
Panel E – Elderly Participants With Mild/Moderate Hypertension 6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
Panel F – Elderly Participants With Mild/Moderate Hypertension 6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
Panel G – Healthy Participants 8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
Panel H – Participants With Resistant Hypertension In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
Panel I – Participants With Mild to Moderate Hypertension 12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
Panel J – Participants With Mild to Moderate Hypertension 12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
Total Total of all reporting groups

Baseline Measures
    Panel A – Participants With Mild to Moderate Hypertension     Panel B – Participants With Mild to Moderate Hypertension     Panel C – Participants With Mild to Moderate Hypertension     Panel D – Participants With Mild to Moderate Hypertension     Panel E – Elderly Participants With Mild/Moderate Hypertension     Panel F – Elderly Participants With Mild/Moderate Hypertension     Panel G – Healthy Participants     Panel H – Participants With Resistant Hypertension     Panel I – Participants With Mild to Moderate Hypertension     Panel J – Participants With Mild to Moderate Hypertension     Total  
Number of Participants  
[units: participants]
  8     8     8     7     9     9     10     8     18     18     103  
Age  
[units: years]
Mean (Standard Deviation)
  46.1  (6.3)     41.3  (10.8)     42.0  (11.4)     42.7  (10.8)     72.6  (4.2)     69.9  (2.5)     41.5  (11.2)     58.1  (5.6)     51.5  (8.5)     54.8  (9.6)     52.5  (13.2)  
Gender  
[units: participants]
                     
Female     0     0     0     0     4     5     0     3     0     0     12  
Male     8     8     8     7     5     4     10     5     18     18     91  
Central Systolic Blood Pressure (cSBP) [1]
[units: mm Hg]
Mean (Standard Deviation)
  141  (15)     126  (10)     127  (16)     126  (7)     143  (11)     144  (11)     103  (11)     130  (12)     133  (10)     136  (12)     131  (16)  
Heart Rate (HR) [1]
[units: beats per minute]
Mean (Standard Deviation)
  65  (14)     63  (7)     66  (12)     61  (10)     59  (11)     68  (9)     54  (7)     63  (9)     62  (10)     66  (9)     63  (10)  
Augmentation Index (AIx) [1]
[units: percent]
Mean (Standard Deviation)
  23  (8)     13  (12)     11  (18)     10  (12)     31  (7)     30  (6)     5  (15)     20  (11)     19  (9)     23  (7)     19  (13)  
Central Diastolic Blood Pressure (cDBP) [1]
[units: mm Hg]
Mean (Standard Deviation)
  93  (5)     87  (8)     87  (10)     87  (7)     84  (7)     86  (11)     73  (9)     85  (8)     89  (6)     90  (11)     87  (10)  
Peripheral Systolic Blood Pressure (pSBP) [1]
[units: mm Hg]
Mean (Standard Deviation)
  150  (12)     137  (7)     142  (17)     139  (5)     147  (10)     151  (9)     117  (7)     141  (11)     145  (9)     147  (10)     142  (13)  
Peripheral Diastolic Blood Pressure (pDBP) [1]
[units: mm Hg]
Mean (Standard Deviation)
  92  (6)     86  (9)     90  (10)     86  (7)     82  (5)     86  (11)     72  (9)     84  (8)     89  (6)     90  (10)     86  (10)  
[1] N for Panel H = 7; N for Total = 102



  Outcome Measures
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1.  Primary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period) ]

2.  Primary:   Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules   [ Time Frame: Up to 28 days ]

3.  Primary:   Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

4.  Primary:   Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

5.  Primary:   Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

6.  Primary:   Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

7.  Primary:   Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

8.  Primary:   Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

9.  Primary:   Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

10.  Primary:   Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

11.  Primary:   Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

12.  Primary:   Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

13.  Primary:   Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

14.  Primary:   Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

15.  Primary:   Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

16.  Primary:   Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

17.  Primary:   Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]

18.  Primary:   Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose ]

19.  Primary:   Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose ]

20.  Primary:   Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

21.  Primary:   AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]

22.  Primary:   Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

23.  Primary:   Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

24.  Primary:   t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

25.  Primary:   AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]

26.  Primary:   Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose ]

27.  Primary:   Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose ]

28.  Primary:   t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

29.  Primary:   AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)   [ Time Frame: Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]

30.  Primary:   Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)   [ Time Frame: Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

31.  Primary:   Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)   [ Time Frame: Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

32.  Primary:   t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

33.  Primary:   AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]

34.  Primary:   Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose ]

35.  Primary:   Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose ]

36.  Primary:   t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

37.  Primary:   AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)   [ Time Frame: Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]

38.  Primary:   Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)   [ Time Frame: Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

39.  Primary:   Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)   [ Time Frame: Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

40.  Primary:   t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose ]

41.  Secondary:   Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

42.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

43.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

44.  Secondary:   Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

45.  Secondary:   Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

46.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

47.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

48.  Secondary:   Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

49.  Secondary:   Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

50.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

51.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

52.  Secondary:   Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

53.  Secondary:   Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

54.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

55.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

56.  Secondary:   Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

57.  Secondary:   Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

58.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

59.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

60.  Secondary:   Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

61.  Secondary:   Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

62.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

63.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

64.  Secondary:   Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

65.  Secondary:   Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

66.  Secondary:   Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)   [ Time Frame: Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose ]

67.  Secondary:   Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]

68.  Secondary:   Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)   [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose ]


  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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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: NCT01656408     History of Changes
Other Study ID Numbers: 8150-002
2012-002596-34 ( EudraCT Number )
Study First Received: July 12, 2012
Results First Received: March 29, 2016
Last Updated: March 29, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products