A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00037635
First received: May 17, 2002
Last updated: May 6, 2013
Last verified: May 2013

May 17, 2002
May 6, 2013
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 ]
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • End Stage Renal Disease
  • Drug: AMG 073
    30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
  • Drug: Placebo
    30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
  • Experimental: AMG 073
    Intervention: Drug: AMG 073
  • Placebo Comparator: placebo
    Intervention: 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Not Provided
 
NCT00037635
20000172
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP