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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02332824 | A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria | PHASE2 | COMPLETED | 415 | — | — | Oct 16, 2014 | Aug 18, 2016 | Aug 13, 2018 | 68 | Japan |
The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 5 mg | EXPERIMENTAL | TAK-272 5 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 20 mg | EXPERIMENTAL | TAK-272 20 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 40 mg | EXPERIMENTAL | TAK-272 20 mg 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| TAK-272 80 mg | EXPERIMENTAL | TAK-272 20 mg 4 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| Candesartan cilexetil 8 mg | ACTIVE_COMPARATOR | TAK-272 placebo 4 tablets and Candesartan cilexetil 8 mg one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14). |
| Name | Type | Description |
|---|---|---|
| TAK-272 | DRUG | TAK-272 tablets |
| TAK-272 Placebo | DRUG | TAK-272 placebo-matching tablets |
| Candesartan cilexetil | DRUG | Candesartan cilexetil tablets |
| Candesartan cilexetil Placebo | DRUG | Candesartan cilexetil placebo-matching tablets |
Inclusion Criteria: * In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements. * The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. * The participa...