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    Clinical Trial Results:
    Exploratory study to assess the efficacy and safety of calcium pangamate in patients with type 2 diabetes mellitus and dyslipidemia treated with statins.

    Summary
    EudraCT number
    		 2007-002568-89
    Trial protocol
    		 PT  
    Global end of trial date
    07 Jan 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2020
    First version publication date
    23 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NAS SIM-PAN II/2006/001/PT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tecnimede, Sociedade Técnico-Medicinal, S.A.
    Sponsor organisation address
    Zona Industrial da Abrunheira, R. da Tapada Grande, nº 2, Sintra, Portugal, 2710-089
    Public contact
    Head of Medical Department, Tecnimede - Sociedade Técnico-Medicinal, S.A., 00351 210 414 100, dmed.ct@tecnimede.pt
    Scientific contact
    Head of Medical Department, Tecnimede - Sociedade Técnico-Medicinal, S.A., 00351 210 414 100, dmed.ct@tecnimede.pt
    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
    07 Jan 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of Ca PGM 400 mg o.d. for 8 weeks as add-on treatment of statins (lovastatin, simvastatin, pravastatin, atorvastatin, fluvastatin or rosuvastatin) on HDL-C of patients with type 2 diabetes mellitus (DM) and dyslipidemia.
    Protection of trial subjects
    This study was conducted in compliance with the Good Clinical Practice (GCP) of the International Council for Harmonisation (ICH), the World Medical Association’s (WMA) principles of the Declaration of Helsinki, Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001, Directive 2005/28/EC of the European Parliament and the Council of 8 April 2005 and the legislation to clinical trials on medicinal products for human use for Portugal at the time the study was conducted (Law 46/2004 of 19 August 2004).
    Background therapy
    		 The trial design has been selected to allow comparison of the effects on HDL-C of a concomitant administration of a statin with Ca PGM versus a statin alone (combination with placebo of Ca PGM) in patients with type 2 diabetes mellitus and dyslipidemia. Therefore and in order to evaluate this effect, all the patients were being treated with statins (lovastatin, simvastatin, pravastatin, atorvastatin, fluvastatin or rosuvastatin) with no changes in treatment regimen in the 8 weeks prior to Visit 1.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    35
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The start date of recruitment was on 18 February 2011 (1st screening failure) and the date of the last patient recruited was on 06-Nov-2012 (LPFV). Of the 94 patients selected in the screening phase, 60 were randomized into the study, but one patient did not initiate the IMP thus no information about the patient’s condition was evaluated.

    Pre-assignment
    Screening details
    		 Period corresponding to approximately 14 days where the study patients kept the recommended diet and followed the prescribed hypoglycaemic and statin medication, comprised by 2 visits: V1 (week -2) and V2 (week -1; 1 week ± 2 days after V1). This period ended after the performance of all the required procedures to confirm patient’s eligibility.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Neither the patient nor the principal investigator, pharmaceutical services and staff involved in the clinical operations (sponsor and CRO) had access to the treatment being administered to each patient. The double blind was achieved through IMP coding, and not identifying, in the medication labels, the active substance of the IMPs, as well as due to the appearance of both IMPs which was the same as described in the corresponding certificates of analysis.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Ca PGM 400 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcium pangamate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients who were randomized, took 2 tablets of Ca PGM 200 mg in the morning (between 6:30 AM and 11:00 AM), fasting and in a single dose (400mg o.d.).

    Arm title
    		 Group B
    Arm description
    		 Ca PGM Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Calcium pangamate placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients who were randomized, took 2 tablets of Ca PGM placebo in the morning (between 6:30 AM and 11:00 AM), fasting and in a single dose.

    Number of subjects in period 1 [1]
    		Group A Group B
    Started
    30
    29
    Completed
    27
    27
    Not completed
    3
    2
         Patient incorrectly included in the study
    1
    -
         Consent withdrawn by subject
    1
    1
         Changes in lipid lowering/hypoglycemic therapies
    1
    -
         Lost to follow-up
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: For this study 60 patients were randomized (31 patients in Group A (Ca PGM) and 29 patients in Group B (placebo)). However, patient D1803 after performing the study procedures of Visit 3 he/she did not initiate the study medication thus no information about the patient’s condition or study medication intake was evaluated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Ca PGM 400 mg

    Reporting group title
    Group B
    Reporting group description
    		 Ca PGM Placebo

    Reporting group values
    		 Group A Group B Total
    Number of subjects
    		 30 29 59
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 14 34
        From 65-84 years
    		 10 15 25
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.90 ± 7.41 63.72 ± 7.64 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 18
        Male
    		 21 20 41
    Smoking habits
    Units: Subjects
        Yes
    		 4 0 4
        No
    		 13 18 31
        Ex-smoker
    		 13 11 24
    Drinking habits
    Units: Subjects
        Yes
    		 10 9 19
        No
    		 20 20 40
    Post-menopausal (only females)
    Units: Subjects
        Yes
    		 9 9 18
        No
    		 0 0 0
        NA
    		 21 20 41
    Sexual active (only females)
    Units: Subjects
        Yes
    		 6 6 12
        No
    		 2 3 5
        Unknown
    		 1 0 1
        NA
    		 21 20 41
    Height
    Units: meter
        arithmetic mean (standard deviation)
    		 1.66 ± 0.09 1.65 ± 0.07 -
    Heart rate
    Units: bpm
        arithmetic mean (standard deviation)
    		 71.20 ± 11.81 72.79 ± 9.48 -
    Systolic blood pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 133.17 ± 15.57 131.38 ± 14.03 -
    Diastolic blood pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 75.03 ± 10.34 77.69 ± 11.53 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 85.18 ± 12.27 86.02 ± 12.78 -
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 30.96 ± 4.34 31.53 ± 3.85 -
    Framingham risk score
    Units: Points
        arithmetic mean (standard deviation)
    		 13.93 ± 3.26 14.24 ± 3.17 -
    Framingham risk score (%)
    Units: 10-year risk
        arithmetic mean (standard deviation)
    		 12.61 ± 7.84 12.29 ± 8.00 -

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Ca PGM 400 mg

    Reporting group title
    Group B
    Reporting group description
    		 Ca PGM Placebo

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who gave their informed consent and who were randomized were included. Randomized patients were excluded from the ITT analysis in case they fulfil at least one of the following criteria: patients who did not perform the treatment for at least one day; patients for whom it was not possible to collect any data following randomization.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Only subjects who were compliant with the protocol and were characterized by criteria such as the following would be included: the completion of a certain pre-specified minimal exposure to the treatment regimen, i.e., subjects who completed the 8 weeks treatment period; the absence of any major protocol violations including the violation of entry criteria; the availability of measurements of the efficacy variable to be evaluated.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who have completed at least one day of treatment and for whom it was possible to collect any data following randomization were included in the analysis. This population was also used to characterize the study population.

    Primary: Relative mean increase (%) in HDL-C vs. baseline following 8 weeks of treatment (ITT population).

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    End point title
    		 Relative mean increase (%) in HDL-C vs. baseline following 8 weeks of treatment (ITT population).
    End point description
    HDL-C: High density lipoprotein-cholesterol.
    End point type
    Primary
    End point timeframe
    Relative mean increase (%) in HDL-C vs. baseline following 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    28
    28
    56
    Units: HDL-C variation (%)
        arithmetic mean (standard deviation)
    4.31 ± 10.64
    2.79 ± 9.39
    3.55 ± 9.97
    Statistical analysis title
    		 Relative mean increase (%) in HDL-C
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.574
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 3.86

    Primary: Relative mean increase (%) in HDL-C vs. baseline following 8 weeks of treatment (PP population).

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    End point title
    		 Relative mean increase (%) in HDL-C vs. baseline following 8 weeks of treatment (PP population).
    End point description
    HDL-C: High density lipoprotein-cholesterol.
    End point type
    Primary
    End point timeframe
    Relative mean increase (%) in HDL-C vs. baseline following 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    23
    25
    48
    Units: HDL-C variation (%)
        arithmetic mean (standard deviation)
    4.01 ± 10.89
    3.53 ± 9.55
    3.76 ± 10.11
    Statistical analysis title
    		 Relative mean increase (%) in HDL-C
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.872
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.46
         upper limit
    		 5.5

    Secondary: Relative mean decrease (%) in TG vs. baseline following 8 weeks of treatment (ITT population).

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    End point title
    		 Relative mean decrease (%) in TG vs. baseline following 8 weeks of treatment (ITT population).
    End point description
    TG: Triglycerides.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in TG vs. baseline following 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    28
    28
    56
    Units: TG variation (%)
        arithmetic mean (standard deviation)
    11.65 ± 33.17
    3.72 ± 26.68
    7.69 ± 30.09
    Statistical analysis title
    		 Relative mean decrease (%) in TG
    Comparison groups
    Group B v Group A
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.329
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.08
         upper limit
    		 8.22

    Secondary: Relative mean decrease (%) in TG vs. baseline following 8 weeks of treatment (PP population).

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    End point title
    		 Relative mean decrease (%) in TG vs. baseline following 8 weeks of treatment (PP population).
    End point description
    TG: Triglycerides.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in TG vs. baseline following 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    23
    25
    48
    Units: TG variation (%)
        arithmetic mean (standard deviation)
    9.10 ± 27.91
    -1.22 ± 21.18
    3.72 ± 24.91
    Statistical analysis title
    		 Relative mean decrease (%) in TG
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.16
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -10.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.85
         upper limit
    		 4.22

    Secondary: Relative mean decrease (%) in LDL-C vs. baseline following 8 weeks of treatment (ITT population).

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    End point title
    		 Relative mean decrease (%) in LDL-C vs. baseline following 8 weeks of treatment (ITT population).
    End point description
    LDL-C: Low density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in LDL-C vs. baseline following 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    27
    27
    54
    Units: LDL-C variation (%)
        arithmetic mean (standard deviation)
    2.28 ± 28.28
    8.52 ± 19.51
    5.40 ± 24.27
    Statistical analysis title
    		 Relative mean decrease (%) in LDL-C
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.35
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    6.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.06
         upper limit
    		 19.55

    Secondary: Relative mean decrease (%) in LDL-C vs. baseline following 8 weeks of treatment (PP population).

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    End point title
    		 Relative mean decrease (%) in LDL-C vs. baseline following 8 weeks of treatment (PP population).
    End point description
    LDL-C: Low density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in LDL-C vs. baseline following 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    22
    24
    46
    Units: LDL-C variation (%)
        arithmetic mean (standard deviation)
    3.78 ± 30.99
    8.89 ± 19.78
    6.45 ± 25.59
    Statistical analysis title
    		 Relative mean decrease (%) in LDL-C
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.513
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    5.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 20.83

    Secondary: Relative mean decrease (%) in TC vs. baseline following 8 weeks of treatment (ITT population).

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    End point title
    		 Relative mean decrease (%) in TC vs. baseline following 8 weeks of treatment (ITT population).
    End point description
    TC: Total cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in TC vs. baseline following 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    28
    28
    56
    Units: TC variation (%)
        arithmetic mean (standard deviation)
    2.21 ± 17.70
    4.92 ± 13.00
    3.56 ± 15.44
    Statistical analysis title
    		 Relative mean decrease (%) in TC
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.517
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.63
         upper limit
    		 11.04

    Secondary: Relative mean decrease (%) in TC vs. baseline following 8 weeks of treatment (PP population).

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    End point title
    		 Relative mean decrease (%) in TC vs. baseline following 8 weeks of treatment (PP population).
    End point description
    TC: Total cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in TC vs. baseline following 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    23
    25
    48
    Units: TC variation (%)
        arithmetic mean (standard deviation)
    2.46 ± 18.81
    4.44 ± 13.23
    3.49 ± 16.00
    Statistical analysis title
    		 Relative mean decrease (%) in TC
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.678
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.59
         upper limit
    		 11.55

    Secondary: Relative mean decrease (%) in TC/HDL-C ratio vs. baseline following 8 weeks of treatment (ITT population).

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    End point title
    		 Relative mean decrease (%) in TC/HDL-C ratio vs. baseline following 8 weeks of treatment (ITT population).
    End point description
    TC: Total cholesterol; HDL-C: High density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in TC/HDL-C ratio vs. baseline following 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    28
    28
    56
    Units: TC/HDL-C variation (%)
        arithmetic mean (standard deviation)
    -1.83 ± 15.09
    3.57 ± 14.10
    0.87 ± 14.73
    Statistical analysis title
    		 Relative mean decrease (%) in TC/HDL-C ratio
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.172
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.43
         upper limit
    		 13.23

    Secondary: Relative mean decrease (%) in TC/HDL-C ratio vs. baseline following 8 weeks of treatment (PP population).

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    End point title
    		 Relative mean decrease (%) in TC/HDL-C ratio vs. baseline following 8 weeks of treatment (PP population).
    End point description
    TC: Total cholesterol; HDL-C: High density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in TC/HDL-C ratio vs. baseline following 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    23
    25
    48
    Units: TC/HDL-C variation (%)
        arithmetic mean (standard deviation)
    -1.33 ± 16.10
    2.48 ± 14.32
    0.65 ± 15.16
    Statistical analysis title
    		 Relative mean decrease (%) in the TC/HDL-C ratio
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.392
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.07
         upper limit
    		 12.71

    Secondary: Relative mean decrease (%) in non-HDL-C/HDL-C ratio vs. baseline following 8 weeks of treatment (ITT population).

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    End point title
    		 Relative mean decrease (%) in non-HDL-C/HDL-C ratio vs. baseline following 8 weeks of treatment (ITT population).
    End point description
    HDL-C: High density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in non-HDL-C/HDL-C ratio vs. baseline following 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    28
    28
    56
    Units: non-HDL-C/HDL-C variation (%)
        arithmetic mean (standard deviation)
    -1.46 ± 19.68
    3.10 ± 18.81
    0.82 ± 19.21
    Statistical analysis title
    		 Relative mean decrease(%) in non-HDL-C/HDL-C ratio
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.379
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    4.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.75
         upper limit
    		 14.88

    Secondary: Relative mean decrease (%) in non-HDL-C/HDL-C ratio vs. baseline following 8 weeks of treatment (PP population).

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    End point title
    		 Relative mean decrease (%) in non-HDL-C/HDL-C ratio vs. baseline following 8 weeks of treatment (PP population).
    End point description
    HDL-C: High density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Relative mean decrease (%) in non-HDL-C/HDL-C ratio vs. baseline following 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    23
    25
    48
    Units: non-HDL-C/HDL-C variation (%)
        arithmetic mean (standard deviation)
    -0.73 ± 21.12
    1.49 ± 19.00
    0.43 ± 19.86
    Statistical analysis title
    		 Relative mean decrease(%) in non-HDL-C/HDL-C ratio
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.705
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 13.94

    Secondary: Proportion of patients who have achieved the HDL-C goal of HDL-C > 45.0 mg/dL for males and > 55.0 mg/dL for females (ITT population).

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    End point title
    		 Proportion of patients who have achieved the HDL-C goal of HDL-C > 45.0 mg/dL for males and > 55.0 mg/dL for females (ITT population).
    End point description
    HDL-C: High density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Proportion of patients who have achieved the HDL-C goal of HDL-C > 45.0 mg/dL for males and > 55.0 mg/dL for females after 8 weeks of treatment (ITT population).
    End point values
    		 Group A Group B ITT population
    Number of subjects analysed
    28
    28
    56
    Units: Patients
        Yes
    4
    4
    8
        No
    24
    24
    48
    Statistical analysis title
    		 Proportion of patients who achieved HDL-C goal
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of patients who have achieved the HDL-C goal of HDL-C > 45.0 mg/dL for males and > 55.0 mg/dL for females (PP population).

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    End point title
    		 Proportion of patients who have achieved the HDL-C goal of HDL-C > 45.0 mg/dL for males and > 55.0 mg/dL for females (PP population).
    End point description
    HDL-C: High density lipoprotein-cholesterol.
    End point type
    Secondary
    End point timeframe
    Proportion of patients who have achieved the HDL-C goal of HDL-C > 45.0 mg/dL for males and > 55.0 mg/dL for females after 8 weeks of treatment (PP population).
    End point values
    		 Group A Group B PP population
    Number of subjects analysed
    23
    25
    48
    Units: Patients
        Yes
    3
    4
    7
        No
    20
    21
    41
    Statistical analysis title
    		 Proportion of patients who achieved the HDL-C goal
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the study, it was the responsibility of the investigator to collect all AEs (both serious and non-serious) and to notify the sponsor of these events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Serious adverse events
    		 Group A Group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 29 (6.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Group A Group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 30 (26.67%)
    10 / 29 (34.48%)
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Phlebitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Gastrointestinal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Leukocyturia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Eye infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2010
    The study sample size has been updated; the randomization procedures have been updated to reflect the change on study sample size.
    26 Mar 2010
    Change from single blind study to double blind study; update of schedule of events by removing the AEs assessment during the screening period (V1 and V2) and replacing the assessment of cardiovascular disease risk factors by assessment of coronary heart disease risk factors; it has been added a reference indicating that patient’s toxic habits would also be collected as demographic data; replacement of assessment of cardiovascular disease risk factors by assessment of coronary heart disease risk factors, performed using the Framingham score; total cholesterol has been added as a laboratory parameter for lipid profile; it has been added a reference regarding the possibility for unblinding in case of the occurrence of SAEs which could jeopardize patient’s safety.
    21 Jun 2010
    Clarification of the withdrawal criterion nº 2 in order to specify which laboratory values changes are considered for study withdrawal; a new withdrawal criterion (13. Unknown) has been added to describe those situations where the contact with the patient is lost.
    09 Jun 2011
    Corrections performed in the concomitant medication section (allowed and prohibited) in order to be in accordance with the information mentioned in the inclusion/exclusion criteria and other sections of the protocol; it has been removed the mention to diet from sections of study design and schedule of events in order to be in accordance with the information mentioned in the inclusion criteria and other sections of the protocol.
    09 Sep 2011
    Removal of an inclusion criterion concerning the range of serum concentration of triglycerides (>150,0 and < 500,0 mg/dl).

    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.
    None reported
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