| August 2, 2002 |
| May 14, 2009 |
| May 2002 |
| July 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 - final 10 weeks of study ] [ 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 NCT00042653 on ClinicalTrials.gov Archive Site |
- To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase [ Time Frame: Efficacy Assessment phase - final 10 weeks of study ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase [ Time Frame: Efficacy Assessment phase - final 10 weeks of study ] [ Designated as safety issue: No ]
- To evaluate the safety of AMG 073 compared with placebo [ Time Frame: Entire study - 26 weeks ] [ Designated as safety issue: Yes ]
|
- To evaluate the efficacy of AMG 073 compared with placebo by determing: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase
- To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during 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 Patients on Dialysis |
| A Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis) |
This 6 month 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, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
- Secondary Hyperparathyroidism
- End Stage Renal Disease
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- Drug: Placebo
- Drug: AMG 073
|
- Experimental: AMG 073
- Placebo Comparator: Placebo
|
| Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. Epub 2005 Feb 2. |
| |
| Completed |
| 380 |
| July 2003 |
| July 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 |
|
| |
| NCT00042653 |
| Global Development Leader, Amgen Inc. |
| 20000188 |
| Amgen |
|
|
|
| Amgen |
| May 2009 |
