Status:
COMPLETED
A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism
Lead Sponsor:
Amgen
Conditions:
Hyperparathyroidism, Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multicenter, open-label, single-arm, extension study was designed to evaluate long-term tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after they completed t...
Eligibility Criteria
Inclusion
- Successfully completed the parent study 990120
- Agreed to use highly effective (in the opinion of the principal investigator) contraceptive measures throughout the study
- Were able to comprehend and were willing to give written informed consent for participation in the study
Exclusion
- Pregnant or breast-feeding
- Had a psychiatric disorder that interfered with the understanding and giving of informed consent or compliance with protocol requirements
- Had any other condition that reduced the chance of obtaining data (eg, known poor compliance)
- Participating in another investigational study at the time of study entry
- Had any unstable medical condition, defined as having been hospitalized within 28 days before day 1, or otherwise unstable in the judgment of the investigator
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00936988
Start Date
November 1 2000
End Date
December 1 2005
Last Update
May 8 2013
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