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Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01350999
First received: May 9, 2011
Last updated: July 28, 2016
Last verified: July 2016
Results First Received: June 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertriglyceridemia
Interventions: Drug: omega-3-acid ethyl esters 90 (TAK-085)
Drug: Eicosapentaenoic acid-ethyl (EPA)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 50 investigative sites in Japan from 11 November 2009 to 11 January 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with hypertriglyceridemia were randomized to receive omega-3-acid ethyl esters 90 (TAK-085) 2 g once daily or TAK-085 2 g twice daily or EPA-E 0.6 g three-times daily.

Reporting Groups
  Description
TAK-085 2 g TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
TAK-085 4 g TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
EPA-E 1.8 g Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.

Participant Flow:   Overall Study
    TAK-085 2 g   TAK-085 4 g   EPA-E 1.8 g
STARTED   165   171   167 
Treated   165   171   167 
COMPLETED   157   157   146 
NOT COMPLETED   8   14   21 
Adverse Event                4                9                10 
Voluntary withdrawal                3                4                6 
Difficulty Making it to Study Visit                1                1                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
TAK-085 2 g TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
TAK-085 4 g TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
EPA-E 1.8 g Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
Total Total of all reporting groups

Baseline Measures
   TAK-085 2 g   TAK-085 4 g   EPA-E 1.8 g   Total 
Overall Participants Analyzed 
[Units: Participants]
 165   171   167   503 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.0  (10.95)   55.9  (10.12)   55.8  (9.27)   55.9  (10.11) 
Age, Customized 
[Units: Participants]
       
≥20 - <65 years   119   134   136   389 
≥65 - ≤74 years   46   37   31   114 
Gender 
[Units: Participants]
       
Female   47   50   48   145 
Male   118   121   119   358 
Region of Enrollment 
[Units: Participants]
       
Japan   165   171   167   503 
Menopause Status 
[Units: Participants]
       
Yes   38   42   39   119 
No   5   7   5   17 
Unknown   4   1   4   9 
Not Applicable   118   121   119   358 
Height, Categorical 
[Units: Participants]
       
<160 cm   48   45   48   141 
≥160 - <170 cm   67   77   66   210 
≥170 cm   50   49   53   152 
Height 
[Units: Cm]
Mean (Standard Deviation)
 164.2  (9.40)   164.0  (8.69)   164.4  (9.65)   164.2  (9.23) 
Weight, Categorical 
[Units: Participants]
       
<60 kg   32   34   32   98 
≥60.0 - <70.0 kg   57   53   43   153 
≥70.0 - <80.0 kg   44   50   57   151 
≥80.0 kg   32   34   35   101 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 70.02  (12.291)   70.46  (12.097)   71.61  (13.311)   70.70  (12.568) 
Body Mass Index, Categorical 
[Units: Participants]
       
<25.0 kg/m^2   77   72   60   209 
≥25.0 - <30.0 kg/m^2   71   74   83   228 
≥30.0 kg/m^2   17   25   24   66 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.90  (3.673)   26.11  (3.526)   26.33  (3.301)   26.12  (3.500) 
Smoking Classification 
[Units: Participants]
       
Never Smoked   59   56   47   162 
Current Smoker   52   47   58   157 
Ex-Smoker   54   68   62   184 
Waist Circumference, Categorical 
[Units: Participants]
       
Male <85.0 cm   22   29   19   70 
Male ≥85.0 cm   96   92   100   288 
Female <90.0 cm   26   30   26   82 
Female ≥90.0 cm   21   20   22   63 
Waist Circumference 
[Units: Cm]
Mean (Standard Deviation)
 90.39  (8.607)   90.75  (9.169)   91.16  (9.284)   90.77  (9.015) 
Coronary Artery Disease (CAD) Category [1] 
[Units: Participants]
       
Category I   7   9   3   19 
Category II   70   71   56   197 
Category III   86   86   102   274 
History of CAD   2   5   6   13 
[1] CAD Patient Categories define the degree of risk of CAD according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. Categories are classified by the degree of risks in the patient [e.g, smoking, hypertension, excluding level of low density lipoprotein cholesterol (LDL-C)]. Category I=Low risk (best), Category II=Middle risk, Category III=High Risk and History of CAD.
Hypertension 
[Units: Participants]
       
Yes   110   115   115   340 
No   55   56   52   163 
Diabetes Mellitus (Including Impaired Glucose Tolerance) 
[Units: Participants]
       
Yes   50   63   71   184 
No   115   108   96   319 
Low High Density Lipoprotein - Cholesterol (HDL-C) 
[Units: Participants]
       
Yes   42   39   45   126 
No   123   132   122   377 
Administration of 3-hydroxy 3-methylglutaryl coenzyme A (HMGCoA) Reductase Inhibitor 
[Units: Participants]
       
Yes   64   66   65   195 
No   101   105   102   308 
Triglycerides, Categorical [1] 
[Units: Participants]
       
<150 mg/dL   16   12   14   42 
≥150 - <300 mg/dL   103   107   109   319 
≥300 - <500 mg/dL   38   43   37   118 
≥500 mg/dL   7   7   7   21 
[1] The number of participants with available triglyceride data are 164, 169 and 167 in each treatment arm, respectively.
Triglycerides [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 254.7  (97.80)   270.0  (101.19)   264.2  (111.62)   263.0  (103.71) 
[1] The number of participants with available triglyceride data are 164, 169 and 167 in each treatment arm, respectively.
Low Density Lipoprotein - Cholesterol (LDL-C), Categorical 
[Units: Participants]
       
<140 mg/dL   101   116   102   319 
≥140 mg/dL   64   55   65   184 
Low Density Lipoprotein - Cholesterol (LDL-C) 
[Units: mg/dL]
Mean (Standard Deviation)
 133.2  (29.85)   129.0  (30.26)   129.3  (33.00)   130.5  (31.06) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: 52 Weeks ]

2.  Primary:   Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs   [ Time Frame: 52 Weeks ]

3.  Primary:   Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight   [ Time Frame: 52 Weeks ]

4.  Primary:   Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration   [ Time Frame: 52 Weeks ]

5.  Primary:   Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis   [ Time Frame: 52 Weeks ]

6.  Secondary:   Percent Change From Baseline in Triglyceride Level   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]

7.  Secondary:   Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]

8.  Secondary:   Percent Change From Baseline in Total Cholesterol   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]

9.  Secondary:   Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]

10.  Secondary:   Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01350999     History of Changes
Other Study ID Numbers: TAK-085/OCT-001
JapicCTI-090936 ( Registry Identifier: JapicCTI )
U1111-1120-7892 ( Registry Identifier: WHO )
JapicCTI-R140451 ( Registry Identifier: JapicCTI )
Study First Received: May 9, 2011
Results First Received: June 1, 2016
Last Updated: July 28, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare