Efficacy of TAK-085 in Participants With Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

Official title:

A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350973
• Other study ID #: TAK-085/CCT-002
• Secondary ID: JapicCTI-090972U
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2011
• Last updated: February 1, 2012
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Description:

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.

2. Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Exclusion Criteria:

1. Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.

2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).

3. Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).

4. Participants who have been diagnosed with pancreatitis.

5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.

6. Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• TAK-085
TAK-085 2 g, capsules, orally, once daily for up to 12 weeks.
• TAK-085
TAK-085, 2 g, capsules, orally, twice daily for up to 12 weeks.
• Eicosapentaenoic acid-ethyl (EPA-E)
EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from Baseline in Triglyceride Level (Final Visit)	The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to baseline. Values defined as follows: Baseline= the mean of the values at Weeks -4, -2 and 0; End of study drug administration= the mean of values at Weeks 10 and 12 (as a general rule, the mean of values at Week 10 and 12 will be used, but in case of withdrawal, the mean of the last 2 evaluable values will be used; if the time interval of the last 2 evaluable values is more than 2 weeks apart, only the last evaluable value will be used).	Baseline and Final Visit (up to 12 weeks).	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 4)	The percentage change between triglycerides collected at week 4 relative to baseline.	Baseline and Week 4.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 8)	The percentage change between triglycerides collected at week 8 relative to baseline.	Baseline and Week 8.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 4)	The percentage change between low-density lipoprotein cholesterol collected at week 4 relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.	Baseline and Week 4.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 8)	The percentage change between low-density lipoprotein cholesterol collected at week 8 relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.	Baseline and Week 8.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 10)	The percentage change between low-density lipoprotein cholesterol collected at week 10 relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.	Baseline and Week 10.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 12)	The percentage change between low-density lipoprotein cholesterol collected at week 12 or final visit relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 4)	The percentage change between total cholesterol measured at week 4 relative to baseline.	Baseline and Week 4.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 8)	The percentage change between total cholesterol measured at week 8 relative to baseline.	Baseline and Week 8.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 10)	The percentage change between total cholesterol measured at week 10 relative to baseline.	Baseline and Week 10.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 12)	The percentage change between total cholesterol measured at week 12 or final visit relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 4)	The percentage change between high-density lipoprotein cholesterol collected at week 4 relative to baseline.	Baseline and Week 4.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 8)	The percentage change between high-density lipoprotein cholesterol collected at week 8 relative to baseline.	Baseline and Week 8.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 10)	The percentage change between high-density lipoprotein cholesterol collected at week 10 relative to baseline.	Baseline and Week 10.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 12)	The percentage change between high-density lipoprotein cholesterol collected at week 12 or final visit relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 4)	The percentage change between non-high-density lipoprotein cholesterol collected at week 4 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 4	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 8)	The percentage change between non-high-density lipoprotein cholesterol collected at week 8 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 8.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 10)	The percentage change between non-high-density lipoprotein cholesterol collected at week 10 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 10.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 12)	The percentage change between non-high-density lipoprotein cholesterol collected at week 12 or final visit relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 12.	No
Secondary	Number of Participants with Adverse Events	Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.	12 Weeks.	Yes
Secondary	Change from Baseline in Vital Signs (Week 4)	Change from baseline in vital signs collected at week 4 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 4.	Yes
Secondary	Change from Baseline in Vital Signs (Week 8)	Change from baseline in vital signs collected at week 8 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 8.	Yes
Secondary	Change from Baseline in Vital Signs (Week 10)	Change from baseline in vital signs collected at week 10 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 10.	Yes
Secondary	Change from Baseline in Vital Signs (Week 12)	Change from baseline in vital signs collected at week 12 or final visit relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 12.	Yes
Secondary	Change from Baseline in Weight (Week 4)	Change from baseline in participant's weight measured at week 4 relative to baseline.	Baseline and Week 4.	Yes
Secondary	Change from Baseline in Weight (Week 8)	Change from baseline in participant's weight measured at week 8 relative to baseline.	Baseline and Week 8.	Yes
Secondary	Change from Baseline in Weight (Week 10)	Change from baseline in participant's weight measured at week 10 relative to baseline.	Baseline and Week 10.	Yes
Secondary	Change from Baseline in Weight (Week 12)	Change from baseline in participant's weight measured at week 12 or final visit relative to baseline.	Baseline and Week 12.	Yes
Secondary	Number of Participants with Abnormal Laboratory Values	The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.	12 Weeks.	Yes
Secondary	Change from Baseline in Electrocardiograms	Change from baseline in electrocardiogram measured at week 12 relative to baseline.	Baseline and Week 12.	Yes
Secondary	Percent Change from Baseline in Triglyceride Level (Week 12)	The percentage change between triglycerides collected at week 12 or final visit relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 10)	The percentage change between triglycerides collected at week 10 relative to baseline.	Baseline and Week 10.	No