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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.
No text entered.

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  
Number of Participants  
[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  
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 [2]
[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  
Triglycerides [2]
[units: mg/dL]
Mean (Standard Deviation)
  254.7  (97.80)     270.0  (101.19)     264.2  (111.62)     263.0  (103.71)  
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)  
[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.
[2] The number of participants with available triglyceride data are 164, 169 and 167 in each treatment arm, respectively.



  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