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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00527267 |
Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.
Condition | Intervention | Phase |
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Hyperparathyroidism |
Drug: Placebo Drug: AMG 073 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 320 |
Study Start Date: | February 2002 |
Study Completion Date: | April 2003 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 073: Experimental
AMG 073
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Drug: AMG 073
30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo
30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000183 |
Study First Received: | September 6, 2007 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00527267 |
Health Authority: | United States: Food and Drug Administration |
Parathyroid Diseases Hyperparathyroidism, Secondary Hyperparathyroidism Kidney Failure, Chronic |
Neoplasm Metastasis Endocrine System Diseases Endocrinopathy Kidney Diseases |