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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02463071 | AZD0585 Phase III Long-term Study in Japan | PHASE3 | COMPLETED | 383 | — | — | Jun 10, 2015 | Mar 11, 2017 | Oct 1, 2018 | 26 | Japan |
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
| Arm | Type | Description |
|---|---|---|
| AZD0585 2g group | EXPERIMENTAL | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
| AZD0585 4g group | EXPERIMENTAL | AZD0585 1g × 4 capsules once daily |
| Placebo control group | PLACEBO_COMPARATOR | AZD0585 placebo 1g × 4 capsules once daily |
| Name | Type | Description |
|---|---|---|
| AZD0585 | DRUG | 1g soft capsule |
| AZD0585 placebo | DRUG | 1g soft capsule |
Key Inclusion Criteria: * Japanese men or women, ≥20 years of age. * Subjects must meet all of the following criteria; 1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL 2. %TG change between Visit 2 and Visit 3 must be within 30% 3. %LDL-C cha...