| May 17, 2002 |
| February 20, 2008 |
| December 2001 |
| March 2003 (final data collection date for primary outcome measure) |
| To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. [ Time Frame: efficacy assessment phase (last 14 weeks of treatment) ] [ Designated as safety issue: No ] |
| To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. |
| Complete list of historical versions of study NCT00037635 on ClinicalTrials.gov Archive Site |
- To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase [ Time Frame: efficacy assessment phase (last 14 weeks of treatment) ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase [ Time Frame: efficacy assessment phase (last 14 weeks of treatment) ] [ Designated as safety issue: No ]
- To evaluate the safety of AMG 073 compared with placebo. [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
|
- To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase
- To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase
- To evaluate the safety of AMG 073 compared with placebo.
|
| |
| A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients |
| A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis |
This 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
- Secondary Hyperparathyroidism
- End Stage Renal Disease
|
- Drug: AMG 073
- Drug: Placebo
|
| |
| Martin KJ, Juppner H, Sherrard DJ, Goodman WG, Kaplan MR, Nassar G, Campbell P, Curzi M, Charytan C, McCary LC, Guo MD, Turner SA, Bushinsky DA. First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl. Kidney Int. 2005 Sep;68(3):1236-43. |
| |
| Completed |
| 400 |
| March 2003 |
| March 2003 (final data collection date for primary outcome measure) |
- Patients must be receiving hemodialysis; * Have elevated parathyroid hormone levels; * Not be pregnant or nursing; and * Not have had a heart attack in the last 3 months.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00037635 |
| Global Development Leader, Amgen Inc. |
| 20000172 |
| Amgen |
|
|
|
| Amgen |
| February 2008 |
