Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)
NCT03776058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2018-12-14
Summary
The primary objectives were to assess the safety and tolerability of twice daily (BID) doses of 65 mg cinacalcet administered orally to adults with primary HPT.
Conditions
- Primary Hyperparathyroidism
Interventions
- DRUG
-
Cinacalcet
Tablets for oral administration
- DRUG
-
Tablets for oral administration
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-06-15
- Primary Completion
- 2000-12-26
- Completion
- 2000-12-26
- FDA Drug
- Yes
More Related Trials
-
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis
NCT00042653 ·Status: COMPLETED ·Phase: PHASE3
-
Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
NCT00094484 ·Status: COMPLETED ·Phase: PHASE3
-
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
NCT01181531 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of a Cincalcet Suppression Test
NCT01103206 ·Status: COMPLETED ·Phase: PHASE4
-
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
NCT01896232 ·Status: COMPLETED ·Phase: PHASE3
-
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
NCT03299244 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects
NCT00527267 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
NCT01932970 ·Status: COMPLETED ·Phase: PHASE3
-
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
NCT01439867 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
NCT02138838 ·Status: TERMINATED ·Phase: PHASE3
-
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
NCT07122401 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
NCT03123406 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
NCT00037635 ·Status: COMPLETED ·Phase: PHASE3
-
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
NCT00042432 ·Status: COMPLETED ·Phase: PHASE2
-
12-month Study of AMG 073 in Renal Osteodystrophy
NCT00527085 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
NCT01785849 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
NCT03283098 ·Status: COMPLETED ·Phase: PHASE1
-
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
NCT02341417 ·Status: COMPLETED ·Phase: PHASE3
-
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
NCT00117052 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
NCT00977080 ·Status: COMPLETED ·Phase: PHASE4
-
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
NCT01191762 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01788046 ·Status: COMPLETED ·Phase: PHASE3
-
Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment
NCT04637360 ·Status: COMPLETED ·Phase: NA
-
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
NCT01101113 ·Status: COMPLETED ·Phase: PHASE4
-
Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant
NCT01011114 ·Status: TERMINATED ·Phase: NA