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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00975221 | Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy | PHASE3 | COMPLETED | 67 | — | — | Mar 10, 2010 | Dec 21, 2012 | Oct 17, 2018 | 47 | United States, Australia +5 |
| NCT00936988 | A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism | PHASE2 | COMPLETED | 45 | — | — | Nov 1, 2000 | Dec 1, 2005 | May 8, 2013 | - | — |
| NCT00936650 | A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT) | PHASE2 | COMPLETED | 78 | — | — | Nov 1, 1999 | Jun 1, 2001 | May 8, 2013 | - | — |
| Arm | Type | Description |
|---|---|---|
| Cinacalcet | EXPERIMENTAL | Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. |
| Name | Type | Description |
|---|---|---|
| Cinacalcet | DRUG | Administered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID). |
| Placebo | DRUG | Administered orally following the same tiitration regimen as the experimental arm. |
Inclusion Criteria: * age ≥ 18 years * diagnosis of primary hyperparathyroidism (HPT) * subjects must have the following laboratory values: 1. local/historical laboratory result showing a corrected total serum calcium \> 1 mg/dL (0.25 mmol/L) above the upper limit of normal and ≤ 12.5 mg/d...