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A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer
This study has been completed.
First Received: May 17, 2002   Last Updated: November 12, 2009   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00037518
  Purpose

This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.


Condition Intervention Phase
Hyperparathyroidism
Parathyroid Neoplasms
Drug: AMG 073
Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Changes in serum calcium and PTH

Secondary Outcome Measures:
  • Safety and tolerability of cinacalcet

Estimated Enrollment: 46
Study Start Date: April 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Patients must have parathyroid carcinoma or severe primary hyperparathyroidism; * Abnormally elevated calcium levels above 12.5 mg/dL; * Not be pregnant or nursing; * Not have had any type of cancer other than parathyroid carcinoma within the last 5 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037518

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20000204
Study First Received: May 17, 2002
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00037518     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Severe primary hyperparathyroidism
Parathyroid carcinoma

Additional relevant MeSH terms:
Parathyroid Diseases
Parathyroid Neoplasms
Neoplasms
Neoplasms by Site
Hyperparathyroidism
Head and Neck Neoplasms
Endocrine System Diseases
Hyperparathyroidism, Primary
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on March 18, 2010