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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of DRL-17822 in Patients with Type II Hyperlipidemia

    Summary
    EudraCT number
    		 2011-001023-21
    Trial protocol
    		 IT  
    Global end of trial date
    10 Jun 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 May 2019
    First version publication date
    05 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRL-17822/CD/004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01388816
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Reddy's Laboratories Limited
    Sponsor organisation address
    Innovation Plaza, Survey No. 42,45,46 & 54, Bachupally, Qutubullapur, Hyderabad, India, 500090
    Public contact
    Regulatory Operations Europe, PHARMANET Ltd., 44 8702420780, regopseurope@pharmanet.com
    Scientific contact
    Regulatory Operations Europe, PHARMANET Ltd., 44 8702420780, regopseurope@pharmanet.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
    14 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.
    Protection of trial subjects
    Timely and complete recording of all AEs assists the Sponsor in identifying any untoward medical occurrence.
    Background therapy
    		 None
    Evidence for comparator
    		 Placebo Comparator: Placebo capsule The 2-week placebo run-in period in this study was included to minimize these effects and to assess the effects on lipid profiles related primarily to receipt of DRL-17822. The placebo comparator arm was included to compare and find out the true effects of DRL-17822 on efficacy and safety
    Actual start date of recruitment
    28 Jul 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
    Poland: 30
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Ukraine: 125
    Worldwide total number of subjects
    176
    EEA total number of subjects
    51
    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)
    144
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 362 patients were screened with 186 patients being screen failures. A total of 176 patients received placebo run-in and were randomized equally in the 4 treatment groups.The majority of patients (71%, [125/17 6] patients) were recruited in Ukraine (125), Italy (21) and Poland (30). Recruitment date July 2011 & completion date May 2012

    Pre-assignment
    Screening details
    		 A total of 362 patients with type II hyperlipidemia were screened with 186 patients being screen failures. A total of 176 patients received placebo run-in and were randomized equally in the 4 treatment groups.

    Period 1
    Period 1 title
    Placebo-run-in period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    double dummy technique

    Arms
    Arm title
    		 Placebo run-in
    Arm description
    		 Placebo run-in period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    During single-blind placebo phase, eligible patients received Placebo for DRL-17822 along with instruction on diet and this phase was up to 2 weeks.

    Number of subjects in period 1
    		Placebo run-in
    Started
    176
    Completed
    176
    Period 2
    Period 2 title
    Randomization Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Double dummy technique

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DRL-17822 50 mg
    Arm description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRL-17822 50 mg Capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Arm title
    		 DRL-17822 150 mg
    Arm description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRL-17822 150 mg capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Arm title
    		 DRL-17822 300 mg
    Arm description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRL-17822 300 mg Capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Arm title
    		 Placebo capsules
    Arm description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Number of subjects in period 2
    		DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Started
    43
    44
    44
    45
    Completed
    39
    41
    44
    43
    Not completed
    4
    3
    0
    2
         Consent withdrawn by subject
    1
    1
    -
    2
         Adverse event, non-fatal
    2
    -
    -
    -
         Non compliance
    -
    1
    -
    -
         Lost to follow-up
    1
    -
    -
    -
         Protocol deviation
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo run-in
    Reporting group description
    		 Placebo run-in period

    Reporting group values
    		 Placebo run-in Total
    Number of subjects
    		 176 176
    Age categorical
    Male or female, 18 to 70 years of age, inclusive. Female patients had to be post-menopausal or surgically sterile
    Units: Subjects
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        Age 18-70 years
    		 176 176
    Gender categorical
    Male or female, 18 to 70 years of age, inclusive. Female patients had to be post-menopausal or surgically sterile
    Units: Subjects
        Female
    		 99 99
        Male
    		 77 77

    End points

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    End points reporting groups
    Reporting group title
    Placebo run-in
    Reporting group description
    		 Placebo run-in period
    Reporting group title
    DRL-17822 50 mg
    Reporting group description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Reporting group title
    DRL-17822 150 mg
    Reporting group description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Reporting group title
    DRL-17822 300 mg
    Reporting group description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Reporting group title
    Placebo capsules
    Reporting group description
    		 This period of the study was double-blind. Study drug was taken orally once daily, immediately after breakfast, for 28 consecutive days

    Primary: Percent Change in HDL-C From Baseline

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    End point title
    		 Percent Change in HDL-C From Baseline
    End point description
    End point type
    Primary
    End point timeframe
    Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    84.2 (69.8 to 98.6)
    122.1 (107.8 to 136.3)
    160.6 (146.5 to 174.6)
    3.2 (-10.8 to 17.3)
    Statistical analysis title
    		 Efficacy analysis
    Statistical analysis description
    The primary efficacy analysis was performed on the Intent-To-Treat (ITT) population. Percent change in HDL-C was analyzed using an Analysis of Variance (ANOVA) model to examine the differences between DRL-17822 dose levels and Placebo treatment. Each DRL-17822 treatment group was compared with placebo using Dunnett’s test
    Comparison groups
    DRL-17822 150 mg v DRL-17822 300 mg v DRL-17822 50 mg v Placebo capsules
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Changes in LDL

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    End point title
    		 Changes in LDL
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame: 28 days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    -15.4 (-26.3 to -4.5)
    -18.7 (-29.5 to -7.9)
    -39.4 (-50.1 to -28.8)
    4.9 (-5.8 to 15.5)
    No statistical analyses for this end point

    Secondary: Changes in HDL-C/LDL-C Ratio

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    End point title
    		 Changes in HDL-C/LDL-C Ratio
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame: 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    -15.4 (-26.3 to -4.5)
    -18.7 (-29.5 to -7.9)
    -39.4 (-50.1 to -28.8)
    0.6 (-41.2 to 42.3)
    No statistical analyses for this end point

    Secondary: change in Total Cholesterol

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    End point title
    		 change in Total Cholesterol
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame : 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    -0.9 (-5.3 to 3.5)
    -0.8 (-5.2 to 3.5)
    -0.8 (-5.1 to 3.5)
    1.5 (-2.9 to 5.8)
    No statistical analyses for this end point

    Secondary: Changes in Triglycerides

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    End point title
    		 Changes in Triglycerides
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame : 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    -14.2 (-26.7 to -1.7)
    0.9 (-11.5 to 13.2)
    -11.3 (-23.5 to 1.0)
    4.5 (-7.7 to 16.7)
    No statistical analyses for this end point

    Secondary: Changes in Apolipoproteins (Apo A1)

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    End point title
    		 Changes in Apolipoproteins (Apo A1)
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame: 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    35.0 (29.0 to 41.1)
    44.8 (38.8 to 50.8)
    59.1 (53.2 to 65.1)
    1.8 (-4.1 to 7.7)
    No statistical analyses for this end point

    Secondary: Changes in Apolipoproteins (Apo B)

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    End point title
    		 Changes in Apolipoproteins (Apo B)
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame : 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    -15.1 (-20.5 to -9.7)
    -22.2 (-27.6 to -16.9)
    -28.9 (-34.2 to -23.6)
    2.9 (-2.4 to 8.2)
    No statistical analyses for this end point

    Secondary: Changes in Apolipoproteins (Apo E)

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    End point title
    		 Changes in Apolipoproteins (Apo E)
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame: 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    2.6 (-15.3 to 20.6)
    10.9 (-6.9 to 28.6)
    32.5 (15.0 to 50.1)
    3.9 (-13.7 to 21.4)
    No statistical analyses for this end point

    Secondary: Changes in Apolipoproteins (Apo Lp(a))

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    End point title
    		 Changes in Apolipoproteins (Apo Lp(a))
    End point description
    Change from baseline (LOCF, ITT population)
    End point type
    Secondary
    End point timeframe
    Time Frame: 28 Days
    End point values
    		 DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg Placebo capsules
    Number of subjects analysed
    42
    43
    44
    44
    Units: Percentage
        arithmetic mean (full range (min-max))
    -26.2 (-63.9 to 11.4)
    10.0 (-26.2 to 46.2)
    -37.7 (-75.4 to -0.1)
    2.8 (-34.4 to 40.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time Frame: 28 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Placebo Capsule
    Reporting group description
    		 -

    Reporting group title
    DRL-17822 50 mg
    Reporting group description
    		 -

    Reporting group title
    DRL-17822 150 mg
    Reporting group description
    		 -

    Reporting group title
    DRL-17822 300 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Capsule DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Capsule DRL-17822 50 mg DRL-17822 150 mg DRL-17822 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 45 (17.78%)
    4 / 43 (9.30%)
    6 / 43 (13.95%)
    2 / 44 (4.55%)
    Investigations
    Pyrexia
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    0
    1
    1
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 43 (2.33%)
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    1
    1
    4
    0
    Abdominal pain
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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