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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00037635 |
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.
Condition | Intervention | Phase |
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Secondary Hyperparathyroidism End Stage Renal Disease |
Drug: AMG 073 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), 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: | 400 |
Study Start Date: | December 2001 |
Study Completion Date: | March 2003 |
Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
AMG 073: Experimental |
Drug: AMG 073
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
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placebo: Placebo Comparator |
Drug: Placebo
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000172 |
Study First Received: | May 17, 2002 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00037635 |
Health Authority: | United States: Food and Drug Administration |
Parathyroid Diseases Renal Insufficiency Hyperparathyroidism, Secondary Urologic Diseases Hyperparathyroidism Renal Insufficiency, Chronic |
Kidney Failure, Chronic Neoplasm Metastasis Endocrine System Diseases Endocrinopathy Kidney Diseases Kidney Failure |
Neoplasms Neoplastic Processes Pathologic Processes |