Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sensipar · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cinacalcet | EXPERIMENTAL | All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm. |
| Name | Type | Description |
|---|---|---|
| Sensipar (Cinacalcet HCl) | DRUG | All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48. |
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria: * One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be \>/= 300 pg/mL. * One serum calcium determination obtained from the central laboratory must be \...
Sensipar is used for secondary hyperparathyroidism, a condition that commonly occurs in patients with end stage renal disease who are on dialysis. The drug is being studied in this patient population to evaluate its effects on bone health through bone biopsy analysis.
Sensipar is developed by Amgen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical research on Sensipar for the treatment of secondary hyperparathyroidism in dialysis patients.
Sensipar is in Phase 2 clinical development. It is an investigational small molecule being studied for secondary hyperparathyroidism. The drug is not approved and remains in clinical trials to evaluate its safety and efficacy in the target patient population.
Sensipar is associated with one completed Phase 2 clinical trial, NCT00261950, titled "Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease." The trial enrolled 110 participants across multiple countries including the United States, Belgium, and the United Kingdom.
Sensipar is the brand name for the drug cinacalcet, a small molecule calcimimetic used to treat secondary hyperparathyroidism. The clinical trial data provided refers to Sensipar, which is the marketed name for cinacalcet in the United States.