Clinical Trials Logo
  1. Home
  2. Hyperparathyroidism, Primary
  3. NCT00936650

A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)

Hyperparathyroidism, Primary Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Dose-Titration Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)

Clinical Trial Summary

This randomized, placebo-controlled study in patients with primary HPT was designed to evaluate the efficacy, safety, pharmacokinetics, and health-related quality of life (HRQOL) of AMG 073 when administered 2 times a day (BID). The study consisted of 3 phases: a 12-week dose-titration phase, a 12-week maintenance phase, and a 28-week follow-up phase.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00936650
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 2
Start date November 1999
Completion date June 2001
View Details
See also
  Status Clinical Trial Phase
Completed NCT03764007 - 18F-Fluorocholine for the Detection of Parathyroid Adenomas Phase 2/Phase 3
Not yet recruiting NCT05556499 - The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism
Completed NCT00928408 - PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
Completed NCT00936988 - 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 Phase 2
Recruiting NCT04948671 - Primary Hyperparathyroidism and Gut Microbiota
Completed NCT02417389 - Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism Phase 4
Completed NCT00975221 - Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy Phase 3
Recruiting NCT04895631 - 18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas Phase 3
Not yet recruiting NCT04126954 - Study on the Use of Cinacalcet in Phosphocalcic Context.
Recruiting NCT05152927 - Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy N/A
Recruiting NCT06230380 - Autofluorescence in Surgery for Primary Hyperparathyroidism N/A
Completed NCT03091140 - Alterations in Muscle's Functional Characteristics After Parathyroid Surgery for Primary Hyperparathyroidism.
Completed NCT03324893 - FCH PET/MRI Parathyroid Localization N/A
Completed NCT05347082 - Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment N/A