Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01300455
First received: February 17, 2011
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: August 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Sleep Apnea
Interventions: Drug: Suvorexant
Drug: Matching Placebo

  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
Suvorexant (40 mg) Then Placebo In Period 1, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
Placebo Then Suvorexant (40 mg) Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.

Participant Flow for 3 periods

Period 1:   Period 1
    Suvorexant (40 mg) Then Placebo     Placebo Then Suvorexant (40 mg)  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  

Period 2:   Washout
    Suvorexant (40 mg) Then Placebo     Placebo Then Suvorexant (40 mg)  
STARTED     13     13  
COMPLETED     12     13  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

Period 3:   Period 2
    Suvorexant (40 mg) Then Placebo     Placebo Then Suvorexant (40 mg)  
STARTED     12     13  
COMPLETED     12     13  
NOT COMPLETED     0     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
Suvorexant (40 mg) Then Placebo In Period 1, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
Placebo Then Suvorexant (40 mg) Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
Total Total of all reporting groups

Baseline Measures
    Suvorexant (40 mg) Then Placebo     Placebo Then Suvorexant (40 mg)     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: years]
Mean ( Full Range )
  48  
  ( 34 to 63 )  
  50  
  ( 30 to 64 )  
  49  
  ( 30 to 64 )  
Gender  
[units: participants]
     
Female     5     2     7  
Male     8     11     19  



  Outcome Measures
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1.  Primary:   Mean Apnea-Hypopnea Index (AHI)   [ Time Frame: Day 4 ]

2.  Primary:   Number of Participants With an Adverse Event   [ Time Frame: Up to 14 days after last dose ]

3.  Primary:   Number of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: Up to 13 days ]

4.  Secondary:   Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time   [ Time Frame: Day 1 and Day 4 ]

5.  Secondary:   Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%   [ Time Frame: Day 1 and Day 4 ]

6.  Secondary:   Mean Arterial SaO2 for Different Sleep Stages   [ Time Frame: Day 1 and Day 4 ]

7.  Secondary:   Mean AHI   [ Time Frame: Day 1 ]


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01300455     History of Changes
Other Study ID Numbers: 4305-036
Study First Received: February 17, 2011
Results First Received: August 19, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration