PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

NCT ID: NCT00928408

Last Updated: 2018-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-02-29

Brief Summary

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This is a multicentre, descriptive observational study of adult patients with primary HPT receiving cinacalcet in clinical practice in a number of countries in Europe. Patients will be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected prospectively for up to 1 year from initiation. Data will continue to be collected from patients discontinuing cinacalcet before the end of this period.

Detailed Description

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Conditions

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Hyperparathyroidism, Primary

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Cinacalcet

Cinacalcet

Intervention Type DRUG

Interventions

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Cinacalcet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age at the time of first administration of cinacalcet
* patients with primary HPT who have initiated cinacalcet within 1 month before enrolment in the study
* provision of informed consent (if required)

Exclusion Criteria

* previous use of cinacalcet (other than within 1 month before enrolment)
* diagnosed secondary HPT
* other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Langdahl BL, Ralston SH. Diagnosis and management of primary hyperparathyroidism in Europe. QJM. 2012 Jun;105(6):519-25. doi: 10.1093/qjmed/hcr225. Epub 2012 May 7.

Reference Type BACKGROUND
PMID: 22566664 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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PRIMARA

Identifier Type: -

Identifier Source: secondary_id

20070363

Identifier Type: -

Identifier Source: org_study_id

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