Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01516151 | Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia | PHASE2 | COMPLETED | 289 | — | — | Dec 1, 2011 | Sep 1, 2013 | Jan 8, 2014 | 38 | Canada |
The percent change in fasting blood circulating serum TGs between baseline and 4 weeks of treatment.
| Arm | Type | Description |
|---|---|---|
| Group A | ACTIVE_COMPARATOR | 0.5g total CaPre™ from baseline to week 4 and 1.0g total CaPre™ from week 4 to week 8 |
| Group B | ACTIVE_COMPARATOR | 1.0g total CaPre™ from baseline to week 4 and 2.0g total CaPre™ from week 4 to week |
| Group C | ACTIVE_COMPARATOR | 2.0g total CaPre™ from baseline to week 4 and 4.0g total CaPre™ from week 4 to week 8 |
| Group D | OTHER | Standard of care |
| Group E | ACTIVE_COMPARATOR | 4.0g total CaPre™ from baseline to week 8 |
| Name | Type | Description |
|---|---|---|
| CaPre™ | DIETARY_SUPPLEMENT | 1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks |
| Lipid Lowering Medication | DRUG | Patient will be treated as per the Standard of care. |
Inclusion Criteria: * Male and female adults aged 18 to 75 years; * Fasting plasma levels of TG \> 2.28 and \< 10 mmol/L (200 and 877 mg/dL) on two occasions within 2 weeks (screening and baseline/part 1 visits). * Patients who are currently not on pharmacotherapy for hyperlipidemia and according t...