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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00042653 |
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.
Condition | Intervention | Phase |
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Secondary Hyperparathyroidism End Stage Renal Disease |
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 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) |
Estimated Enrollment: | 380 |
Study Start Date: | May 2002 |
Study Completion Date: | July 2003 |
Primary Completion Date: | July 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 of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo
30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000188 |
Study First Received: | August 2, 2002 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00042653 |
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 |