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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00037518
Collaborator
(none)
46

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: AMG 073
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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.
Study Start Date :
Apr 1, 2001

Outcome Measures

Primary Outcome Measures

  1. Changes in serum calcium and PTH []

Secondary Outcome Measures

  1. Safety and tolerability of cinacalcet []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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

Locations

No locations specified.

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00037518
Other Study ID Numbers:
  • 20000204
First Posted:
May 20, 2002
Last Update Posted:
May 8, 2013
Last Verified:
May 1, 2013

Study Results

No Results Posted as of May 8, 2013