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

Hypertriglyceridemia Clinical Trial

Official title:

A Phase 3, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Long-term Administration of TAK-085 to the Patients With Hypertriglyceridemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350999
• Other study ID #: TAK-085/OCT-001
• Secondary ID: JapicCTI-090936U
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2011
• Last updated: August 23, 2011
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• 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 is to determine the safety and efficacy 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, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• TAK-085
TAK-085 2 g, capsules, orally, once daily for up to 52 weeks.
• TAK-085
TAK-085 2 g, capsules, orally, twice daily for up to 52 weeks.
• Eicosapentaenoic acid-ethyl
EPA-E 0.6 g, capsules, orally, three-times daily for up to 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 the last dose of study drug.	52 Weeks.	Yes
Primary	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
Primary	Change from Baseline in Vital Signs (Week 8)	Change from baseline in vital signs collected at week 4 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 8.	Yes
Primary	Change from Baseline in Vital Signs (Week 12)	Change from baseline in vital signs collected at week 12 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 12.	Yes
Primary	Change from Baseline in Vital Signs (Week 16)	Change from baseline in vital signs collected at week 16 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 16.	Yes
Primary	Change from Baseline in Vital Signs (Week 20)	Change from baseline in vital signs collected at week 20 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 20.	Yes
Primary	Change from Baseline in Vital Signs (Week 24)	Change from baseline in vital signs collected at week 24 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 24.	Yes
Primary	Change from Baseline in Vital Signs (Week 28)	Change from baseline in vital signs collected at week 28 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 28.	Yes
Primary	Change from Baseline in Vital Signs (Week 32)	Change from baseline in vital signs collected at week 32 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 32.	Yes
Primary	Change from Baseline in Vital Signs (Week 36)	Change from baseline in vital signs collected at week 36 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 36.	Yes
Primary	Change from Baseline in Vital Signs (Week 40)	Change from baseline in vital signs collected at week 40 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 40.	Yes
Primary	Change from Baseline in Vital Signs (Week 44)	Change from baseline in vital signs collected at week 44 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 44.	Yes
Primary	Change from Baseline in Vital Signs (Week 48)	Change from baseline in vital signs collected at week 48 relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 48.	Yes
Primary	Change from Baseline in Vital Signs (Week 52)	Change from baseline in vital signs collected at week 52 or final visit relative to baseline. Vital signs include sitting blood pressure and pulse.	Baseline and Week 52.	Yes
Primary	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
Primary	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
Primary	Change from Baseline in Weight (Week 12)	Change from baseline in participant's weight measured at week 12 relative to baseline.	Baseline and Week 12.	Yes
Primary	Change from Baseline in Weight (Week 16)	Change from baseline in participant's weight measured at week 16 relative to baseline.	Baseline and Week 16.	Yes
Primary	Change from Baseline in Weight (Week 20)	Change from baseline in participant's weight measured at week 20 relative to baseline.	Baseline and Week 20.	Yes
Primary	Change from Baseline in Weight (Week 24)	Change from baseline in participant's weight measured at week 24 relative to baseline.	Baseline and Week 24.	Yes
Primary	Change from Baseline in Weight (Week 28)	Change from baseline in participant's weight measured at week 28 relative to baseline.	Baseline and Week 28.	Yes
Primary	Change from Baseline in Weight (Week 32)	Change from baseline in participant's weight measured at week 32 relative to baseline.	Baseline and Week 32.	Yes
Primary	Change from Baseline in Weight (Week 36)	Change from baseline in participant's weight measured at week 36 relative to baseline.	Baseline and Week 36.	Yes
Primary	Change from Baseline in Weight (Week 40)	Change from baseline in participant's weight measured at week 40 relative to baseline.	Baseline and Week 40.	Yes
Primary	Change from Baseline in Weight (Week 44)	Change from baseline in participant's weight measured at week 44 relative to baseline.	Baseline and Week 44.	Yes
Primary	Change from Baseline in Weight (Week 48)	Change from baseline in participant's weight measured at week 48 relative to baseline.	Baseline and Week 48.	Yes
Primary	Change from Baseline in Weight (Week 52)	Change from baseline in participant's weight measured at week 52 or final visit relative to baseline.	Baseline and Week 52.	Yes
Primary	Change from Baseline in Electrocardiograms (Week 12)	Change from baseline in electrocardiogram measured at week 12 relative to baseline.	Baseline and Week 12.	Yes
Primary	Change from Baseline in Electrocardiograms (Week 24)	Change from baseline in electrocardiogram measured at week 24 relative to baseline.	Baseline and Week 24.	Yes
Primary	Change from Baseline in Electrocardiograms (Week 36)	Change from baseline in electrocardiogram measured at week 36 relative to baseline.	Baseline and Week 36.	Yes
Primary	Change from Baseline in Electrocardiograms (Week 52)	Change from baseline in electrocardiogram measured at week 52 or final visit relative to baseline.	Baseline and Week 52.	Yes
Primary	Number of Participants with Abnormal Laboratory Values	The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.	52 Weeks	Yes
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 Triglyceride Level (Week 12)	The percentage change between triglycerides collected at week 12 relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 16)	The percentage change between triglycerides collected at week 16 relative to baseline.	Baseline and Week 16.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 20)	The percentage change between triglycerides collected at week 20 relative to baseline.	Baseline and Week 20.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 24)	The percentage change between triglycerides collected at week 24 relative to baseline.	Baseline and Week 24.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 28)	The percentage change between triglycerides collected at week 28 relative to baseline.	Baseline and Week 28.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 32)	The percentage change between triglycerides collected at week 32 relative to baseline.	Baseline and Week 32.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 36)	The percentage change between triglycerides collected at week 36 relative to baseline.	Baseline and Week 36.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 40)	The percentage change between triglycerides collected at week 40 relative to baseline.	Baseline and Week 40.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 44)	The percentage change between triglycerides collected at week 44 relative to baseline.	Baseline and Week 44.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 48)	The percentage change between triglycerides collected at week 48 relative to baseline.	Baseline and Week 48.	No
Secondary	Percent Change from Baseline in Triglyceride Level (Week 52)	The percentage change between triglycerides collected at week 52 or final visit relative to baseline.	Baseline and Week 52.	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.	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.	Baseline and Week 8.	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 relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 16)	The percentage change between low-density lipoprotein cholesterol collected at week 16 relative to baseline.	Baseline and Week 16.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 20)	The percentage change between low-density lipoprotein cholesterol collected at week 20 relative to baseline.	Baseline and Week 20.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 24)	The percentage change between low-density lipoprotein cholesterol collected at week 24 relative to baseline.	Baseline and Week 24.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 28)	The percentage change between low-density lipoprotein cholesterol collected at week 28 relative to baseline.	Baseline and Week 28.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 32)	The percentage change between low-density lipoprotein cholesterol collected at week 32 relative to baseline.	Baseline and Week 32.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 36)	The percentage change between low-density lipoprotein cholesterol collected at week 36 relative to baseline.	Baseline and Week 36.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 40)	The percentage change between low-density lipoprotein cholesterol collected at week 40 relative to baseline.	Baseline and Week 40.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 44)	The percentage change between low-density lipoprotein cholesterol collected at week 44 relative to baseline.	Baseline and Week 44.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 48)	The percentage change between low-density lipoprotein cholesterol collected at week 48 relative to baseline.	Baseline and Week 48.	No
Secondary	Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 52)	The percentage change between low-density lipoprotein cholesterol collected at week 52 or final visit relative to baseline.	Baseline and Week 52.	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 12)	The percentage change between total cholesterol measured at week 12 relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 16)	The percentage change between total cholesterol measured at week 16 relative to baseline.	Baseline and Week 16.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 20)	The percentage change between total cholesterol measured at week 20 relative to baseline.	Baseline and Week 20.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 24)	The percentage change between total cholesterol measured at week 24 relative to baseline.	Baseline and Week 24.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 28)	The percentage change between total cholesterol measured at week 28 relative to baseline.	Baseline and Week 28.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 32)	The percentage change between total cholesterol measured at week 32 relative to baseline.	Baseline and Week 32.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 36)	The percentage change between total cholesterol measured at week 36 relative to baseline.	Baseline and Week 36.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 40)	The percentage change between total cholesterol measured at week 40 relative to baseline.	Baseline and Week 40.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 44)	The percentage change between total cholesterol measured at week 44 relative to baseline.	Baseline and Week 44.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 48)	The percentage change between total cholesterol measured at week 48 relative to baseline.	Baseline and Week 48.	No
Secondary	Percent Change from Baseline in Total Cholesterol (Week 52)	The percentage change between total cholesterol measured at week 52 or final visit relative to baseline.	Baseline and Week 52.	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 12)	The percentage change between high-density lipoprotein cholesterol collected at week 12 relative to baseline.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 16)	The percentage change between high-density lipoprotein cholesterol collected at week 16 relative to baseline.	Baseline and Week 16.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 20)	The percentage change between high-density lipoprotein cholesterol collected at week 20 relative to baseline.	Baseline and Week 20.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 24)	The percentage change between high-density lipoprotein cholesterol collected at week 24 relative to baseline.	Baseline and Week 24.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 28)	The percentage change between high-density lipoprotein cholesterol collected at week 28 relative to baseline.	Baseline and Week 28.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 32)	The percentage change between high-density lipoprotein cholesterol collected at week 32 relative to baseline.	Baseline and Week 32.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 36)	The percentage change between high-density lipoprotein cholesterol collected at week 36 relative to baseline.	Baseline and Week 36.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 40)	The percentage change between high-density lipoprotein cholesterol collected at week 40 relative to baseline.	Baseline and Week 40.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 44)	The percentage change between high-density lipoprotein cholesterol collected at week 44 relative to baseline.	Baseline and Week 44.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 48)	The percentage change between high-density lipoprotein cholesterol collected at week 48 relative to baseline.	Baseline and Week 48.	No
Secondary	Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 52)	The percentage change between high-density lipoprotein cholesterol collected at week 52 or final visit relative to baseline.	Baseline and Week 52.	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 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 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 12)	The percentage change between non-high-density lipoprotein cholesterol collected at week 12 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 12.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 16)	The percentage change between non-high-density lipoprotein cholesterol collected at week 16 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 16.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 20)	The percentage change between non-high-density lipoprotein cholesterol collected at week 20 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 20.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 24)	The percentage change between non-high-density lipoprotein cholesterol collected at week 24 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 24.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 28)	The percentage change between non-high-density lipoprotein cholesterol collected at week 28 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 28.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 32)	The percentage change between non-high-density lipoprotein cholesterol collected at week 32 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 32.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 36)	The percentage change between non-high-density lipoprotein cholesterol collected at week 36 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 36.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 40)	The percentage change between non-high-density lipoprotein cholesterol collected at week 40 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 40.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 48)	The percentage change between non-high-density lipoprotein cholesterol collected at week 48 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 48.	No
Secondary	Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 52)	The percentage change between non-high-density lipoprotein cholesterol collected at week 52 or final visit relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.	Baseline and Week 52.	No