Trial record 5 of 9 for:    "Parathyroid carcinoma"

A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00037518
First received: May 17, 2002
Last updated: May 6, 2013
Last verified: May 2013
  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 4

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00037518     History of Changes
Other Study ID Numbers: 20000204
Study First Received: May 17, 2002
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Severe primary hyperparathyroidism
Parathyroid carcinoma

Additional relevant MeSH terms:
Neoplasms
Hyperparathyroidism
Parathyroid Neoplasms
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014