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Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

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ClinicalTrials.gov Identifier: NCT01097616
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : September 1, 2014
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE April 1, 2010
Results First Submitted Date  ICMJE August 19, 2014
Results First Posted Date  ICMJE September 1, 2014
Last Update Posted Date September 21, 2018
Actual Study Start Date  ICMJE May 5, 2010
Actual Primary Completion Date September 9, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 [ Time Frame: Baseline and Month 1 ]
    sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 [ Time Frame: Baseline and Month 3 ]
    sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 [ Time Frame: Baseline and Month 1 ]
    WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 [ Time Frame: Baseline and Month 3 ]
    WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 [ Time Frame: Baseline and Month 1 ]
    sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 [ Time Frame: Baseline and Month 3 ]
    sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 [ Time Frame: Baseline and Month 1 ]
    LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 [ Time Frame: Baseline and Month 3 ]
    LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase [ Time Frame: Up to 3 months ]
    An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.
  • Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase [ Time Frame: Up to 3 months ]
    An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
  • MK4305 high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 1 ]
  • MK4305 high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 3 ]
  • MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 1 ]
  • MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 3 ]
  • MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 1 ]
  • MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 3 ]
  • MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 1 ]
  • MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 3 ]
Change History Complete list of historical versions of study NCT01097616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1 [ Time Frame: Baseline and Week 1 ]
    sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1 [ Time Frame: Baseline and Month 1 ]
    sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3 [ Time Frame: Baseline and Month 3 ]
    sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1 [ Time Frame: Baseline and Night 1 ]
    WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1 [ Time Frame: Baseline and Month 1 ]
    WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3 [ Time Frame: Baseline and Month 3 ]
    WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1 [ Time Frame: Baseline and Week 1 ]
    sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1 [ Time Frame: Baseline and Month 1 ]
    sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3 [ Time Frame: Baseline and Month 3 ]
    sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
  • Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1 [ Time Frame: Baseline and Night 1 ]
    LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1 [ Time Frame: Baseline and Month 1 ]
    LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
  • Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3 [ Time Frame: Baseline and Month 3 ]
    LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
  • MK4305 high dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Week 1 ]
  • MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Night 1 ]
  • MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Week 1 ]
  • MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Night 1 ]
  • MK4305 low dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Week 1 ]
  • MK4305 low dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 1 ]
  • MK4305 low dose versus placebo: Change from baseline in subjective total sleep time [ Time Frame: Month 3 ]
  • MK4305 low dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Night 1 ]
  • MK4305 low dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 1 ]
  • MK4305 low dose versus placebo: Change from baseline in wake time after persistent sleep onset [ Time Frame: Month 3 ]
  • MK4305 low dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Week 1 ]
  • MK4305 low dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 1 ]
  • MK4305 low dose versus placebo: Change from baseline in subjective time to sleep onset [ Time Frame: Month 3 ]
  • MK4305 low dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Night 1 ]
  • MK4305 low dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 1 ]
  • MK4305 low dose versus placebo: Change from baseline in latency to onset of persistent sleep [ Time Frame: Month 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study A
Brief Summary This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Insomnia
Intervention  ICMJE
  • Drug: Suvorexant High Dose (HD)
    Suvorexant 40 mg + placebo matching suvorexant 20 mg for participants <65 years old; Suvorexant 30 mg + placebo matching suvorexant 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week double-blind (DB) Run-out (RO) following the TRT/EXT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
    Other Name: MK-4305
  • Drug: Suvorexant Low Dose (LD)
    Suvorexant 20 mg + placebo matching suvorexant 40 mg for participants <65 years old; Suvorexant 15 mg + placebo matching suvorexant 30 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week DB RO following the TRT/EXT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
    Other Name: MK-4305
  • Drug: Comparator: Placebo
    Matching placebos to suvorexant 40 mg and 20 mg for participants <65 years old; matching placebos to suvorexant 30 mg and 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Placebo is a third treatment arm for comparison to the two active (suvorexant) treatment arms during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week DB RO following the TRT/EXT phase, participants in this study arm continue to receive placebo. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
Study Arms  ICMJE
  • Experimental: Suvorexant HD
    Drug
    Intervention: Drug: Suvorexant High Dose (HD)
  • Experimental: Suvorexant LD
    Drug
    Intervention: Drug: Suvorexant Low Dose (LD)
  • Placebo Comparator: Placebo
    Placebo Comparator
    Intervention: Drug: Comparator: Placebo
Publications *

*   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: January 10, 2012)
1023
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2010)
960
Actual Study Completion Date  ICMJE December 7, 2011
Actual Primary Completion Date September 9, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be ≥18 yrs old on the day of signing informed consent
  • Diagnosed with Primary Insomnia
  • Good physical and mental health
  • Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination
  • A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
  • Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
  • Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
  • Regular bedtime is between 9 pm-1 am
  • Willing to refrain from napping while in study
  • Able to read, understand and complete questionnaires and all diaries
  • Willing to limit alcohol, caffeine, and nicotine consumption while in the study
  • For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory

Exclusion Criteria:

  • Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study
  • History or diagnosis of another sleep disorder
  • Difficulty sleeping due to a medical condition
  • History of a neurological disorder
  • History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
  • Ongoing depression
  • History of substance abuse or dependence
  • History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit
  • Taking certain prohibited medications
  • Consumption of the equivalent of >15 cigarettes a day
  • History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Participant is considered morbidly obese
  • Previously randomized in another investigational study of suvorexant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Australia,   Brazil,   Canada,   Denmark,   Finland,   France,   Germany,   Japan,   Peru,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01097616
Other Study ID Numbers  ICMJE 4305-028
2010_520 ( Other Identifier: Merck Registration Number )
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 Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

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