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    Clinical Trial Results:
    A multicenter, Double-blind 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression.

    Summary
    EudraCT number
    		 2010-024371-12
    Trial protocol
    		 ES   SE   FI   AT   GB   IT  
    Global end of trial date
    22 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2016
    First version publication date
    16 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CN162-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01361555
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to compare the long term effect of three target doses of BMS-820836 (0.5, 1, and 2 mg/day) through 54 weeks of follow-up in the change from randomization baseline in mean seated blood pressure in subjects with treatment-resistant depression.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Finland: 28
    Country: Number of subjects enrolled
    France: 71
    Country: Number of subjects enrolled
    United States: 553
    Country: Number of subjects enrolled
    South Africa: 30
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Argentina: 33
    Country: Number of subjects enrolled
    India: 21
    Country: Number of subjects enrolled
    Puerto Rico: 30
    Worldwide total number of subjects
    788
    EEA total number of subjects
    113
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    775
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 119 centers in 12 countries.

    Pre-assignment
    Screening details
    		 A total of 788 subjects were enrolled into the study. Of the 788 subjects enrolled, 321 subjects rolled over from Study CN162-006 (EudraCT Number - 2010-022841-93) and 467 rolled over from Study CN162-007 (EudraCT Number - 2011-000778-71).

    Period 1
    Period 1 title
    Overall Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Subject, Investigator, Assessor and Sponsor remained blinded during the study. Unblinding was performed only in the event of a medical emergency or pregnancy of the individual subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-820836 0.5 mg
    Arm description
    		 Subjects received BMS-820836 0.5 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liafensine
    Investigational medicinal product code
    BMS-820836
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-820836 0.5-mg tablet was administered orally once daily for 54 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 Placebo tablet matching to BMS-820836 0.5 mg and 1 Placebo tablet matching BMS-820836 1 mg were administered once daily for 54 weeks.

    Arm title
    		 BMS-820836 1 mg
    Arm description
    		 Subjects received BMS-820836 1 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liafensine
    Investigational medicinal product code
    BMS-­820836
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 BMS-820836 0.5-mg tablets were administered orally once daily for 54 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 Placebo tablet matching to BMS-820836 1 mg was administered once daily for 54 weeks.

    Arm title
    		 BMS-820836 2 mg
    Arm description
    		 Subjects received BMS-820836 2 mg tablets once daily for 54 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liafensine
    Investigational medicinal product code
    BMS-820836
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 BMS-820836 1-mg tablet and 2 BMS-820836 0.5 mg tablets were administered orally once daily for 54 weeks.

    Number of subjects in period 1
    		BMS-820836 0.5 mg BMS-820836 1 mg BMS-820836 2 mg
    Started
    226
    265
    297
    Completed
    66
    75
    84
    Not completed
    160
    190
    213
         Consent withdrawn by subject
    16
    15
    21
         Poor/Non compliance
    2
    6
    8
         Adverse event, non-fatal
    15
    14
    25
         Subject request to discontinue study treatment
    8
    17
    15
         Pregnancy
    2
    1
    2
         other
    6
    5
    6
         Lost to follow-up
    20
    14
    22
         Subject no longer meets study criteria
    6
    5
    8
         Administrative reason by sponsor
    57
    85
    79
         Lack of efficacy
    28
    28
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMS-820836 0.5 mg
    Reporting group description
    		 Subjects received BMS-820836 0.5 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.

    Reporting group title
    BMS-820836 1 mg
    Reporting group description
    		 Subjects received BMS-820836 1 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.

    Reporting group title
    BMS-820836 2 mg
    Reporting group description
    		 Subjects received BMS-820836 2 mg tablets once daily for 54 weeks.

    Reporting group values
    		 BMS-820836 0.5 mg BMS-820836 1 mg BMS-820836 2 mg Total
    Number of subjects
    		 226 265 297 788
    Age categorical
    Units: Subjects
        <=50 years
    		 140 156 169 465
        >50 years
    		 86 109 128 323
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.71 ( 11.216 ) 46.48 ( 11.122 ) 46.65 ( 11.03 ) -
    Gender categorical
    Units: Subjects
        Female
    		 161 177 212 550
        Male
    		 65 88 85 238

    End points

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    End points reporting groups
    Reporting group title
    BMS-820836 0.5 mg
    Reporting group description
    		 Subjects received BMS-820836 0.5 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.

    Reporting group title
    BMS-820836 1 mg
    Reporting group description
    		 Subjects received BMS-820836 1 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.

    Reporting group title
    BMS-820836 2 mg
    Reporting group description
    		 Subjects received BMS-820836 2 mg tablets once daily for 54 weeks.

    Primary: Change From Baseline through 54 Weeks in Mean of Seated Systolic and Diastolic Blood Pressure

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    End point title
    		 Change From Baseline through 54 Weeks in Mean of Seated Systolic and Diastolic Blood Pressure [1]
    End point description
    Blood pressure in seated position was measured using a blood pressure monitor. The subject was first rested for at least 10 minutes in the seated position. Seated blood pressure was determined from the mean of 3 replicated measurements obtained at 2 minutes apart. Mean seated BP was calculated using the following formula for seated mean arterial pressure (MAP): SeatedMAP = (2*SeDBP + SeSBP)/3. The analysis was performed in all subjects who received at least 1 dose of BMS-820836 during the study. Missing data were not imputed. Here, ‘n’ signifies evaluable subjects for specified categories in respective treatment arms.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12, Week 24, Week 36, Week 48, Week 54
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the study was terminated, all data were summarized descriptively, and no statistical comparisons were performed across dose groups.
    End point values
    		 BMS-820836 0.5 mg BMS-820836 1 mg BMS-820836 2 mg
    Number of subjects analysed
    226
    265
    297
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline (n=225, 263, 295)
    90.37 ( 9.555 )
    93.06 ( 10.228 )
    91.55 ( 9.905 )
        Change at Week 12 (n=178, 218, 247)
    0.15 ( 8.204 )
    0.96 ( 7.08 )
    1.51 ( 8.288 )
        Change at Week 24 (n=149, 183, 195)
    0.59 ( 9.532 )
    0.97 ( 8.016 )
    1.14 ( 9.35 )
        Change at Week 36 (n=101, 137, 146)
    0.81 ( 9.185 )
    1.2 ( 8.525 )
    1.56 ( 9.377 )
        Change at Week 48 (n=71, 92, 103)
    2.64 ( 10.528 )
    0.44 ( 8.482 )
    1.57 ( 8.517 )
        Change at Week 54 (n=61, 66, 79)
    0.96 ( 7.6 )
    2.93 ( 8.808 )
    2.56 ( 9.418 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to Adverse Events

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    End point title
    		 Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to Adverse Events
    End point description
    An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug. The analysis was performed in all subjects who received at least 1 dose of BMS-820836 during the study.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 days after the last dose of the study drug
    End point values
    		 BMS-820836 0.5 mg BMS-820836 1 mg BMS-820836 2 mg
    Number of subjects analysed
    226
    265
    297
    Units: Subjects
        AEs
    171
    185
    230
        SAEs
    7
    13
    9
        Discontinuation due to AEs
    14
    12
    24
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 days post last dose or till start of Washout Phase, whichever is earlier (approximately 58 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    BMS-820836 0.5 mg
    Reporting group description
    		 Subjects received BMS-820836 0.5 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.

    Reporting group title
    BMS-820836 1 mg
    Reporting group description
    		 Subjects received BMS-820836 1 mg and matching placebo to BMS-820836 tablets once daily for 54 weeks.

    Reporting group title
    BMS-820836 2 mg
    Reporting group description
    		 Subjects received BMS-820836 2 mg tablets once daily for 54 weeks.

    Serious adverse events
    		 BMS-820836 0.5 mg BMS-820836 1 mg BMS-820836 2 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 226 (3.10%)
    13 / 265 (4.91%)
    9 / 297 (3.03%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer stage III
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 265 (0.75%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Self injurious behaviour
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery occlusion
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spondylitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis perforated
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 265 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 265 (0.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 265 (0.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS-820836 0.5 mg BMS-820836 1 mg BMS-820836 2 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    173 / 226 (76.55%)
    199 / 265 (75.09%)
    234 / 297 (78.79%)
    Investigations
    Weight increased
         subjects affected / exposed
    16 / 226 (7.08%)
    12 / 265 (4.53%)
    9 / 297 (3.03%)
         occurrences all number
    16
    12
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    39 / 226 (17.26%)
    38 / 265 (14.34%)
    31 / 297 (10.44%)
         occurrences all number
    63
    51
    38
    Dizziness
         subjects affected / exposed
    18 / 226 (7.96%)
    11 / 265 (4.15%)
    12 / 297 (4.04%)
         occurrences all number
    20
    13
    14
    Somnolence
         subjects affected / exposed
    6 / 226 (2.65%)
    9 / 265 (3.40%)
    15 / 297 (5.05%)
         occurrences all number
    7
    10
    17
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 226 (5.31%)
    15 / 265 (5.66%)
    21 / 297 (7.07%)
         occurrences all number
    14
    16
    21
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 226 (5.75%)
    13 / 265 (4.91%)
    23 / 297 (7.74%)
         occurrences all number
    15
    13
    27
    Constipation
         subjects affected / exposed
    7 / 226 (3.10%)
    10 / 265 (3.77%)
    24 / 297 (8.08%)
         occurrences all number
    7
    13
    29
    Dry mouth
         subjects affected / exposed
    8 / 226 (3.54%)
    13 / 265 (4.91%)
    17 / 297 (5.72%)
         occurrences all number
    8
    14
    17
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    10 / 226 (4.42%)
    13 / 265 (4.91%)
    21 / 297 (7.07%)
         occurrences all number
    13
    14
    21
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    14 / 226 (6.19%)
    14 / 265 (5.28%)
    7 / 297 (2.36%)
         occurrences all number
    16
    14
    7
    Arthralgia
         subjects affected / exposed
    10 / 226 (4.42%)
    10 / 265 (3.77%)
    15 / 297 (5.05%)
         occurrences all number
    11
    11
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    21 / 226 (9.29%)
    18 / 265 (6.79%)
    16 / 297 (5.39%)
         occurrences all number
    25
    20
    18
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 226 (5.31%)
    14 / 265 (5.28%)
    21 / 297 (7.07%)
         occurrences all number
    12
    16
    22
    Urinary tract infection
         subjects affected / exposed
    13 / 226 (5.75%)
    13 / 265 (4.91%)
    16 / 297 (5.39%)
         occurrences all number
    15
    13
    17
    Influenza
         subjects affected / exposed
    12 / 226 (5.31%)
    11 / 265 (4.15%)
    5 / 297 (1.68%)
         occurrences all number
    12
    14
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Feb 2012
    The purpose of this amendment was to re-define the research hypothesis, add exploratory objectives and to include guidance for the pharmacological and non-pharmacological treatment interventions for subjects that develop elevated blood pressure during the study.
    16 Jan 2013
    The purpose of this amendment was to revise the dosing recommendations for zolpidem tartrate as per Food and Drug administration recommendation.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early when the primary objective in each of the 2 parent studies CN162-006 (EudraCT Number: 2010-022841-93) and CN162-007 (EudraCT Number: 2011-000778-71) was not achieved.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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